<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03839771</url>
  </required_header>
  <id_info>
    <org_study_id>HO150</org_study_id>
    <secondary_id>2018-000451-41</secondary_id>
    <nct_id>NCT03839771</nct_id>
  </id_info>
  <brief_title>A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy</brief_title>
  <acronym>HOVON150AML</acronym>
  <official_title>A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stichting Hemato-Oncologie voor Volwassenen Nederland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stichting Hemato-Oncologie voor Volwassenen Nederland</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      AML and MDS-EB2 are malignancies of the bone marrow. The standard treatment for these&#xD;
      diseases is chemotherapy. Patients participating have a special type of this disease because&#xD;
      the leukemia cells (blasts) have developed an error in the genetic material (DNA). This error&#xD;
      is called an IDH1 mutation or an IDH2 mutation (a mutation is a change in the DNA), which&#xD;
      leads to changes in specific substances in the leukemia cells. This trial will investigate&#xD;
      whether the addition of the new drugs Ivosidenib (for patients with IDH1 mutation) or&#xD;
      Enasidenib (for patients with IDH2 mutation) to the standard treatment of chemotherapy&#xD;
      controle the disease more effectively and for a longer period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">March 2033</completion_date>
  <primary_completion_date type="Anticipated">March 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Event-free survival (EFS)</measure>
    <time_frame>Approximately up to 60 months following first patient enrollment</time_frame>
    <description>EFS is defined as the time from randomization to failure to achieve CR or CRi after remission induction, death after achieving CR or CRi or relapse after achieving CR or CRi, whichever occurs first. A patient is said to have failed to achieve CR or CRi after induction therapy, if his/her best response during or at completion of the induction treatment is less than CRi. Patients who achieved CR/CRi after remission induction and are not known to have relapsed or died will be censored at the date of last clinical assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Approximately up to 84 months following first patient enrollment</time_frame>
    <description>OS is defined as the time from date of randomization to date of death due to any cause. Patients still alive or lost to follow up will be censored at the time they were last known to be alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse-free survival (RFS) after CR/CRi</measure>
    <time_frame>Approximately up to 60 months following first patient enrollment</time_frame>
    <description>RFS is defined as time from the date of achievement of CR/CRi until relapse or death from any cause, whichever comes first. Patients still in first CR/CRi and alive or lost to follow up will be censored at the date of last clinical assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of relapse (CIR) after CR/CRi</measure>
    <time_frame>Approximately up to 60 months following first patient enrollment</time_frame>
    <description>CIR is measured from the date of achievement of CR/CRi until the date of relapse. Patients not known to have relapsed will be censored on the date of last clinical assessment. Patients who died without relapse will be counted as a competing cause of failure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of death (CID) after CR/CRi</measure>
    <time_frame>Approximately up to 60 months following first patient enrollment</time_frame>
    <description>CID is measured from the date of achievement of CR/CRi until the date of death from any cause. Patients not known to have died will be censored on the date they were last known to be alive. Patients who experienced relapse in CR/CRi will be counted as competing cause of failure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete remission without minimal residual disease (CRMRD-) rate after induction cycle 2</measure>
    <time_frame>Approximately up to 60 months following first patient enrollment</time_frame>
    <description>CRMRD- rate is defined as the percentage of patients who achieved CR or CRi with no evidence of MRD in bone marrow</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency and severity of adverse events according to CTCAE version 5.0</measure>
    <time_frame>Continuously throughout the study, starting from informed consent until 30 days following the last administration of any study drug</time_frame>
    <description>Adverse events will be evaluated using the National Cancer Institute's Common Terminology Criteria for AEs (CTCAE) version 5.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CR/CRi rates after induction cycle 1 and 2</measure>
    <time_frame>Approximately up to 60 months following first patient enrollment</time_frame>
    <description>CR and CRi are determined by the Investigator based on the European LeukemiaNet (ELN2017) recommended response criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CR/CRi rate after remission induction (i.e., CR or CRi as best response during or at completion of induction therapy)</measure>
    <time_frame>Approximately up to 60 months following first patient enrollment</time_frame>
    <description>CR+CRi rate after remission induction is defined as the percentage of patients with best response of CR or CRi during or at completion of induction therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to hematopoietic recovery after each chemotherapy treatment cycle</measure>
    <time_frame>Approximately up to 60 months following first patient enrollment</time_frame>
    <description>Time to hematopoietic recovery is defined as the time from the start of the cycle until recovery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L visual analogue scale (VAS)</measure>
    <time_frame>At entry, 1st day of maintenance, every 3 months during the first year of maintenance, every 6 months during the second year of maintenance until relapse or treatment discontinuation (approximately up to 84 months following first patient enrollment)</time_frame>
    <description>The EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating &quot;health today&quot;. Each domain has 5 levels. Each level has a 1 digit number expressing the level selected for that dimension. These levels are summed up and the self-rated health is recorded on a 20 cm vertical, visual analogue scale, with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC-QLQ-C30 global health status/QoL scale.</measure>
    <time_frame>At entry, 1st day of maintenance, every 3 months during the first year of maintenance, every 6 months during the second year of maintenance until relapse or treatment discontinuation (approximately up to 84 months following first patient enrollment)</time_frame>
    <description>The EORTC QLQ-C30 is a 30-item questionnaire that assesses 5 functional subdomains (physical functioning, role functioning, emotional functioning, cognitive functioning and social functioning), 1 global health status, 3 symptom subdomains (fatigue, nausea and vomiting and pain) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Estimate the average of the items that contribute to the scale; this is the raw score. a higher score represents a higher (&quot;better&quot;) level of functioning, or a higher (&quot;worse&quot;) level of symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">968</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <condition>Myelodysplastic Syndrome With Excess Blasts-2</condition>
  <arm_group>
    <arm_group_label>Arm A: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Cycle 1: day 1-start cycle 2 | Cycle 2: day 1 - start consolidation treatment | Consolidation treatment: day 1 - start maintenance | Maintenance treatment: day 1- day 730 (2 years) |&#xD;
The dosage for Placebo for AG-120 (IDH1): 500 mg dose/day&#xD;
The dosage for Placebo for AG-221 (IDH2): 100mg dose/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: Ivosidenib (IDH1) or Enasidenib (IDH2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cycle 1: day 1-start cycle 2 | Cycle 2: day 1 - start consolidation treatment | Consolidation treatment: day 1 - start maintenance | Maintenance treatment: day 1- day 730 (2 years) |&#xD;
The dosage for AG-120 (IDH1): 500 mg dose/day&#xD;
The dosage for AG-221 (IDH2): 100mg dose/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AG-120</intervention_name>
    <description>250mg tablets</description>
    <arm_group_label>Arm B: Ivosidenib (IDH1) or Enasidenib (IDH2)</arm_group_label>
    <other_name>Ivosidenib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for AG-120</intervention_name>
    <description>250mg tablets</description>
    <arm_group_label>Arm A: Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AG-221</intervention_name>
    <description>100mg tablets</description>
    <arm_group_label>Arm B: Ivosidenib (IDH1) or Enasidenib (IDH2)</arm_group_label>
    <other_name>Enasidenib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for AG-221</intervention_name>
    <description>100mg tablets</description>
    <arm_group_label>Arm A: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Newly diagnosed AML or MDS-EB2 defined according to WHO criteria, with a documented&#xD;
             IDH1 or IDH2 gene mutation (as determined by the clinical trial assay) at a specific&#xD;
             site (IDH1 R132, IDH2 R140, IDH2 R172). AML may be secondary to prior hematological&#xD;
             disorders, including MDS, and/or therapy-related (in which prior disease should have&#xD;
             been documented to have existed for at least 3 months). Patients may have had previous&#xD;
             treatment with hypomethylating agents (HMAs) for MDS. HMAs have to be stopped at least&#xD;
             four weeks before registration&#xD;
&#xD;
          -  Patients with dual mutant FLT3 and IDH1 or IDH2 mutations may be enrolled only if, for&#xD;
             medical or other reasons, treatment with a FLT3 inhibitor is not considered.&#xD;
&#xD;
          -  Considered to be eligible for intensive chemotherapy.&#xD;
&#xD;
          -  ECOG/WHO performance status ≤ 2&#xD;
&#xD;
          -  Adequate hepatic function as evidenced by:&#xD;
&#xD;
               -  Serum total bilirubin ≤ 2.5 × upper limit of normal (ULN) unless considered due&#xD;
                  to Gilbert's disease (e.g. a mutation in UGT1A1) (only for patients in IDH2&#xD;
                  cohort), or leukemic involvement of the liver - following written approval by the&#xD;
                  (Co)Principal Investigator.&#xD;
&#xD;
               -  Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline&#xD;
                  phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to leukemic involvement of&#xD;
                  the liver, following written approval by the Principal Investigator.&#xD;
&#xD;
          -  Adequate renal function as evidenced by creatinine clearance &gt; 40 mL/min based on the&#xD;
             Cockroft-Gault formula for glomerular filtration rate (GFR).&#xD;
&#xD;
          -  Able to understand and willing to sign an informed consent form (ICF).&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Female patient must either:&#xD;
&#xD;
        o Be of nonchildbearing potential: Postmenopausal (defined as at least 1 year without any&#xD;
        menses) prior to screening, or Documented surgically sterile or status posthysterectomy (at&#xD;
        least 1 month prior to screening)&#xD;
&#xD;
        o Or, if of childbearing potential: Agree not to try to become pregnant during the study&#xD;
        and for 6 months after the final study drug administration And have a negative urine or&#xD;
        serum pregnancy test at screening And, if heterosexually active, agree to consistently use&#xD;
        highly effective* contraception per locally accepted standards in addition to a barrier&#xD;
        method starting at screening and throughout the study period and for 6 months after the&#xD;
        final study drug administration.&#xD;
&#xD;
          -  Highly effective forms of birth control include:&#xD;
&#xD;
               -  Consistent and correct usage of established hormonal contraceptives that inhibit&#xD;
                  ovulation,&#xD;
&#xD;
               -  Established intrauterine device (IUD) or intrauterine system (IUS),&#xD;
&#xD;
               -  Bilateral tubal occlusion,&#xD;
&#xD;
               -  Vasectomy (A vasectomy is a highly effective contraception method provided the&#xD;
                  absence of sperm has been confirmed. If not, an additional highly effective&#xD;
                  method of contraception should be used.)&#xD;
&#xD;
               -  Male is sterile due to a bilateral orchiectomy.&#xD;
&#xD;
               -  Sexual abstinence is considered a highly effective method only if defined as&#xD;
                  refraining from heterosexual activity during the entire period of risk associated&#xD;
                  with the study drug. The reliability of sexual abstinence needs to be evaluated&#xD;
                  in relation to the duration of the clinical study and the preferred and usual&#xD;
                  lifestyle of the patient.&#xD;
&#xD;
          -  List is not all inclusive. Prior to enrollment, the investigator is responsible for&#xD;
             confirming patient will utilize highly effective forms of birth control per the&#xD;
             requirements of the CTFG Guidance document 'Recommendations related to contraception&#xD;
             and pregnancy testing in clinical trials', September 2014 (and any updates thereof)&#xD;
             during the protocol defined period.&#xD;
&#xD;
               -  Female patient must agree not to breastfeed starting at screening and throughout&#xD;
                  the study period, and for 2 months and 1 week after the final study drug&#xD;
                  administration.&#xD;
&#xD;
               -  Female patient must not donate ova starting at screening and throughout the study&#xD;
                  period, and for 6 months after the final study drug administration.&#xD;
&#xD;
                    -  Male patient and their female partners who are of childbearing potential&#xD;
                       must be using highly effective contraception per locally accepted standards&#xD;
                       in addition to a barrier method starting at screening and continue&#xD;
                       throughout the study period and for 4 months and 1 week after the final&#xD;
                       study drug administration&#xD;
&#xD;
                    -  Male patient must not donate sperm starting at screening and throughout the&#xD;
                       study period and for 4 months and 1 week after the final study drug&#xD;
                       administration.&#xD;
&#xD;
                         -  Subject agrees not to participate in another interventional study while&#xD;
                            on treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior chemotherapy for AML or MDS-EB2 (with the exception of HMA). Hydroxyurea is&#xD;
             allowed for the control of peripheral leukemic blasts in patients with leukocytosis&#xD;
             (e.g., white blood cell [WBC] counts &gt; 30x109/L).&#xD;
&#xD;
          -  Dual IDH1 and IDH2 mutations.&#xD;
&#xD;
          -  Acute promyelocytic leukemia (APL) with PML-RARA or one of the other pathognomonic&#xD;
             variant fusion genes/chromosome translocations.&#xD;
&#xD;
          -  Blast crisis after chronic myeloid leukemia (CML).&#xD;
&#xD;
          -  Known allergy or suspected hypersensitivity to Ivosidenib or Enasidenib and/or any&#xD;
             exipients.&#xD;
&#xD;
          -  Taking medications with narrow therapeutic windows with potential interaction with&#xD;
             investigational medication (see Appendix I), unless the patient can be transferred to&#xD;
             other medications prior to enrolling or unless the medications can be properly&#xD;
             monitored during the study.&#xD;
&#xD;
          -  Taking P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP)&#xD;
             transporter-sensitive substrate medications (see Appendix J) unless the patient can be&#xD;
             transferred to other medications within ≥ 5 half-lives prior to administration of&#xD;
             ivosidenib or enasidenib, or unless the medications can be properly monitored during&#xD;
             the study.&#xD;
&#xD;
          -  Breast feeding at the start of study treatment.&#xD;
&#xD;
          -  Active infection, including hepatitis B or C or HIV infection that is uncontrolled at&#xD;
             randomization. An infection controlled with an approved or closely monitored&#xD;
             antibiotic/antiviral/antifungal treatment is allowed.&#xD;
&#xD;
          -  Patients with a currently active second malignancy. Patients are not considered to&#xD;
             have a currently active malignancy if they have completed therapy and are considered&#xD;
             by their physician to be at &lt; 30% risk of relapse within one year. However, patients&#xD;
             with the following history/concurrent conditions are allowed:&#xD;
&#xD;
               -  Basal or squamous cell carcinoma of the skin&#xD;
&#xD;
               -  Carcinoma in situ of the cervix&#xD;
&#xD;
               -  Carcinoma in situ of the breast&#xD;
&#xD;
               -  Incidental histologic finding of prostate cancer&#xD;
&#xD;
          -  Significant active cardiac disease within 6 months prior to the start of study&#xD;
             treatment, including New York Heart Association (NYHA) Class III or IV congestive&#xD;
             heart failure (appendix G); myocardial infarction, unstable angina and/or stroke; or&#xD;
             left ventricular ejection fraction (LVEF) &lt; 40% by ultrasound or MUGA scan obtained&#xD;
             within 28 days prior to the start of study treatment.&#xD;
&#xD;
          -  QTc interval using Fridericia's formula (QTcF) ≥ 450 msec or other factors that&#xD;
             increase the risk of QT prolongation or arrhythmic events (e.g., heart failure,family&#xD;
             history of long QT interval syndrome). Prolonged QTc interval associated with bundle&#xD;
             branch block or pacemaking is permitted with written approval of the Principal&#xD;
             Investigator.&#xD;
&#xD;
          -  Taking medications that are known to prolong the QT interval (see Appendix K), unless&#xD;
             deemed critical and without a suitable alternative. In those cases, they may be&#xD;
             administered, but with proper monitoring (see section 10.2, Table 13).&#xD;
&#xD;
          -  Dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the&#xD;
             ingestion or gastrointestinal absorption of orally administered drugs.&#xD;
&#xD;
          -  Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known&#xD;
             CNS leukemia. Evaluation of cerebrospinal fluid (CSF) during screening is only&#xD;
             required if there is a clinical suspicion of CNS involvement by leukemia during&#xD;
             screening.&#xD;
&#xD;
          -  A known medical history of progressive multifocal leukoencephalopathy (PML).&#xD;
&#xD;
          -  Immediately life-threatening, severe complications of leukemia such as uncontrolled&#xD;
             bleeding, pneumonia with hypoxia or shock, and/or severe disseminated intravascular&#xD;
             coagulation&#xD;
&#xD;
          -  Any other medical condition deemed by the Investigator to be likely to interfere with&#xD;
             a patient's ability to give informed consent or participate in the study.&#xD;
&#xD;
          -  Any psychological, familial, sociological or geographical condition potentially&#xD;
             hampering compliance with the study protocol and follow-up schedule.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>B.J. Wouters</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erasmus MC / HOVON</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>B.J. Wouters, Dr.</last_name>
    <phone>+31 10 704 15 60</phone>
    <email>b.wouters@erasmusmc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>K. Doehner, Prof</last_name>
    <phone>+49 731 500 45501</phone>
    <email>konstanze.doehner@uniklinik-ulm.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>AU-Adelaide-FLINDERS</name>
      <address>
        <city>Adelaide</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Adelaide-RAH</name>
      <address>
        <city>Adelaide</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Brisbane-PAH</name>
      <address>
        <city>Brisbane</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Camperdown-RPA</name>
      <address>
        <city>Camperdown</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Canberra-CANBERRAHOSPITAL</name>
      <address>
        <city>Canberra</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Douglas-TOWNSVILLE</name>
      <address>
        <city>Douglas</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Hobart TAS-RHOBART</name>
      <address>
        <city>Hobart</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Launceston TAS-LAUNCESTON</name>
      <address>
        <city>Launceston</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Melbourne-ALFRED</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Melbourne-AUSTIN</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Melbourne-MONASH</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Melbourne-RMELBOURNE</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Melbourne-SVHM</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Perth-FSH</name>
      <address>
        <city>Perth</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Perth-RPH</name>
      <address>
        <city>Perth</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Perth-SCGH</name>
      <address>
        <city>Perth</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Sydney-CONCORD</name>
      <address>
        <city>Sydney</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Sydney-RNSH</name>
      <address>
        <city>Sydney</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Sydney-SVHS</name>
      <address>
        <city>Sydney</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Sydney-WSAH</name>
      <address>
        <city>Sydney</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU-Waratah-CALVARYMATER</name>
      <address>
        <city>Waratah</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>AT-Graz-MEDUNIGRAZ</name>
      <address>
        <city>Graz</city>
        <country>Austria</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>AT-Innsbruck-IMED</name>
      <address>
        <city>Innsbruck</city>
        <country>Austria</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>AT-Linz-ORDENSKLINIKUM</name>
      <address>
        <city>Linz</city>
        <country>Austria</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>AT-Vienna-HANUSCH</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>BE-Antwerpen-ZNASTUIVENBERG</name>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>BE-Brugge-AZBRUGGE</name>
      <address>
        <city>Brugge</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>BE-Brussel-BORDET</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>BE-Brussel-UZBRUSSEL</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>BE-Bruxelles-STLUC</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>BE-Gent-UZGENT</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>BE-Haine-Saint-Paul-JOLIMONT</name>
      <address>
        <city>Haine-Saint-Paul</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>BE-Hasselt-VIRGAJESSE</name>
      <address>
        <city>Hasselt</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>BE-Leuven-UZLEUVEN</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>BE-Liege-CHRCITADELLE</name>
      <address>
        <city>Liège</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>BE-Liege-CHULIEGE</name>
      <address>
        <city>Liège</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>BE-Roeselare-AZDELTA</name>
      <address>
        <city>Roeselare</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>BE-Yvoir-MONTGODINNE</name>
      <address>
        <city>Yvoir</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>EE-Tartu-TARTU</name>
      <address>
        <city>Tartu</city>
        <country>Estonia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FI-Helsinki-HUS</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FI-Tampere-TAYS</name>
      <address>
        <city>Tampere</city>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Amiens-CHUAMIENS</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Angers-CHUANGERS</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Argenteuil-CHARGENTEUIL</name>
      <address>
        <city>Argenteuil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Bayonne-CHCOTEBASQUE</name>
      <address>
        <city>Bayonne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Besançon Cedex-JEANMINJOZ</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Bobigny-AVICENNE</name>
      <address>
        <city>Bobigny</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Chambery-CHMETROPOLESAVOIE</name>
      <address>
        <city>Chambéry</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Le Chesnay cedex-CHVERSAILLES</name>
      <address>
        <city>Chesnay</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Clamart-HIAPERCY</name>
      <address>
        <city>Clamart</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Clermont-Ferrand-ESTAING</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Créteil cedex-CHUMONDOR</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Grenoble cedex 9-CHUGRENOBLE</name>
      <address>
        <city>Grenoble cedex 9</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Lens-CHLENS</name>
      <address>
        <city>Lens</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Lille-CHULILLE</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Limoges-CHULIMOGES</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Lyon Pierre Benite cedex-LYONSUD</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Lyon-LEONBERARD</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Marseille-IPC</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Montpellier-STELOI</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Mulhouse-GHRMSA</name>
      <address>
        <city>Mulhouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Nantes-CHUNANTES</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Nice-CAL</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Nice-LARCHET</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Orléans-CHORLEANS</name>
      <address>
        <city>Orléans</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Paris cedex 10-SAINTLOUIS</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Paris cedex 12-SAINTANTOINE</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Paris cedex 15-NECKER</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Pessac Cedex-CHUBORDEAUX</name>
      <address>
        <city>Pessac</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Poitiers-CHUPOITERS</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Reims-CHREIMS</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Rennes cedex 9-CHURENNES</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Rouen cedex-BECQUEREL</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Strasbourg cedex-HAUTEPIERRE</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Toulouse-CHUTOULOUSE</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Tours cedex-BRETONNEAU</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Vandoeuvre Les Nancy-CHRUNANCY</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FR-Villejuif-GUSTAVEROUSSY</name>
      <address>
        <city>Villejuif</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Bad Saarow-HELIOSBADSAAROW</name>
      <address>
        <city>Bad Saarow</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Berlin-CAMPUSBENFRANKLIN</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Berlin-CAMPUSVIRCHOW</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Berlin-VIVANTESNEUKOLLN</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Berlin-VIVANTESURBAN</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Bochum-RUB</name>
      <address>
        <city>Bochum</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Bonn-UNIBONN</name>
      <address>
        <city>Bonn</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Braunschweig-KLINIKUMBRAUNSCHWEIG</name>
      <address>
        <city>Braunschweig</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Bremen-KBM</name>
      <address>
        <city>Bremen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Dortmund-JOHODORTMUND</name>
      <address>
        <city>Dortmund</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Düsseldorf-MEDUNIDUESSELDORF</name>
      <address>
        <city>Düsseldorf</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Essen-KEM</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Esslingen-KLINIKUMESSLINGEN</name>
      <address>
        <city>Esslingen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Flensburg-MALTESER</name>
      <address>
        <city>Flensburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Giessen-UKGM</name>
      <address>
        <city>Gießen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Goch-KKLE</name>
      <address>
        <city>Goch</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Hamburg-ASKLEPIOSSTGEORG</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Hamburg-ASKLEPIOS</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Hamburg-UKE</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Hamm-EVKHAMM</name>
      <address>
        <city>Hamm</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Hanau-KLINIKUMHANAU</name>
      <address>
        <city>Hanau</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Hannover-MHHANNOVER</name>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Hannover-SILOAHKRH</name>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Herne-MARIENHOSPITALHERNE</name>
      <address>
        <city>Herne</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Homburg-UNIKLINIKSAARLAND</name>
      <address>
        <city>Homburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Karlsruhe-KLINIKUMKARLSRUHE</name>
      <address>
        <city>Karlsruhe</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Lebach-CARITASKHLEBACH</name>
      <address>
        <city>Lebach</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Lemgo-KLINIKUMLIPPE</name>
      <address>
        <city>Lemgo</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Ludwigshafen-KLILU</name>
      <address>
        <city>Ludwigshafen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Luedenscheid-KLINIKUMLUEDENSCHEID</name>
      <address>
        <city>Lüdenscheid</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Magdeburg-OVGU</name>
      <address>
        <city>Magdeburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Mainz-KLINKUNIMAINZ</name>
      <address>
        <city>Mainz</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Mainz-UNIMEDIZINMAINZ</name>
      <address>
        <city>Mainz</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Meschede-HOCHSAUERLAND</name>
      <address>
        <city>Meschede</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Minden-MUEHLENKREISKLINKEN</name>
      <address>
        <city>Minden</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-München-IRZTUM</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-München-MEDUNIMUNCHIN</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Offenburg-ORTENAUKLINIKUM</name>
      <address>
        <city>Offenburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Oldenburg-KLINIKUMOLDENBURG</name>
      <address>
        <city>Oldenburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Passau-KLINIKUMPASSAU</name>
      <address>
        <city>Passau</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Stuttgart-DIAKSTUTTGART</name>
      <address>
        <city>Stuttgart</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Stuttgart-KLINIKUMSTUTTGART</name>
      <address>
        <city>Stuttgart</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Traunstein-TSSOB</name>
      <address>
        <city>Traunstein</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Trier-MUTTERHAUS</name>
      <address>
        <city>Trier</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Tübingen-MEDUNITUEBINGEN</name>
      <address>
        <city>Tübingen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Ulm-UNIKLINKULM</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Villingen-Schwenningen-SBKVS</name>
      <address>
        <city>Villingen-Schwenningen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DE-Wuppertal-HELIOSGESUNDHEIT</name>
      <address>
        <city>Wuppertal</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>IE-Cork-CUH</name>
      <address>
        <city>Cork</city>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>IE-Dublin 8-STJAMES</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>IE-Dublin 9-BEAUMONT</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>IE-Galway-UHGALWAY</name>
      <address>
        <city>Galway</city>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>LT-Vilnius-SANTA</name>
      <address>
        <city>Vilnius</city>
        <country>Lithuania</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>LU-Luxembourg-CHL</name>
      <address>
        <city>Luxembourg</city>
        <country>Luxembourg</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Amersfoort-MEANDERMC</name>
      <address>
        <city>Amersfoort</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Amsterdam-AMC</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Amsterdam-OLVG</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Amsterdam-VUMC</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Arnhem-RIJNSTATE</name>
      <address>
        <city>Arnhem</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Breda-AMPHIA</name>
      <address>
        <city>Breda</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Delft-RDGG</name>
      <address>
        <city>Delft</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Den Bosch-JBZ</name>
      <address>
        <city>Den Bosch</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Den Haag-HAGA</name>
      <address>
        <city>Den Haag</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Dordrecht-ASZ</name>
      <address>
        <city>Dordrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Eindhoven-MAXIMAMC</name>
      <address>
        <city>Eindhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Enschede-MST</name>
      <address>
        <city>Enschede</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Groningen-UMCG</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Leeuwarden-MCL</name>
      <address>
        <city>Leeuwarden</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Leiden-LUMC</name>
      <address>
        <city>Leiden</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Maastricht-MUMC</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Nieuwegein-ANTONIUS</name>
      <address>
        <city>Nieuwegein</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Nijmegen-RADBOUDUMC</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Rotterdam-ErasmusMC</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Utrecht-UMCUTRECHT</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NL-Zwolle-ISALA</name>
      <address>
        <city>Zwolle</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NO-Bergen-HELSEBERGEN</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NO-Oslo-OSLOUH</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NO-Stavanger-HELSESTAVANGER</name>
      <address>
        <city>Stavanger</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NO-Tromsø-NORTHNOORWEGEN</name>
      <address>
        <city>Tromsø</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NO-Trondheim-STOLAV</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>ES-Barcelona-CLINICUB</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>ES-Barcelona-GERMANTRIALS</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>ES-Barcelona-ICODURANREYNALS</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>ES-Barcelona-MUTUATERRASSA</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>ES-Barcelona-PARCDESALUTMAR</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>ES-Barcelona-SANTPAU</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>ES-Barcelona-VHEBRON</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>ES-Girona-ICSTRUETA</name>
      <address>
        <city>Girona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>ES-Madrid-CSGREGORIOMARANON</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>ES-Palma-SSIB</name>
      <address>
        <city>Palma</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>ES-Tarragona-JOAN</name>
      <address>
        <city>Tarragona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>ES-Valencia-MALVARROSA</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>SE-Lund-SUH</name>
      <address>
        <city>Lund</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>SE-Stockholm-KAROLINSKAHUDDINGE</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>SE-Uppsala-UPPSALAUH</name>
      <address>
        <city>Uppsala</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CH-Basel-USB</name>
      <address>
        <city>Basel</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CH-Bellinzona-IOSI</name>
      <address>
        <city>Bellinzona</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CH-Bern-INSEL</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CH-Fribourg-HFR</name>
      <address>
        <city>Fribourg</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CH-Geneve (14)-HCUGE</name>
      <address>
        <city>Geneve</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CH-Lausanne-CHUV</name>
      <address>
        <city>Lausanne</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>CH-Luzern-LUKS</name>
      <address>
        <city>Luzern</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CH-St. Gallen-KSSG</name>
      <address>
        <city>Saint Gallen</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CH-Zürich-USZ</name>
      <address>
        <city>Zürich</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Estonia</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Lithuania</country>
    <country>Luxembourg</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://www.hovon.nl</url>
    <description>HOVON website</description>
  </link>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Anemia, Refractory, with Excess of Blasts</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ivosidenib</mesh_term>
    <mesh_term>Glycine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03839771
org study id: HO150
secondary id: 2018-000451-41
nct id: NCT03839771
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
AML and MDS-EB2 are malignancies of the bone marrow. The standard treatment for these
      diseases is chemotherapy. Patients participating have a special type of this disease because
      the leukemia cells (blasts) have developed an error in the genetic material (DNA). This error
      is called an IDH1 mutation or an IDH2 mutation (a mutation is a change in the DNA), which
      leads to changes in specific substances in the leukemia cells. This trial will investigate
      whether the addition of the new drugs Ivosidenib (for patients with IDH1 mutation) or
      Enasidenib (for patients with IDH2 mutation) to the standard treatment of chemotherapy
      controle the disease more effectively and for a longer period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Event-free survival (EFS)
time frame: Approximately up to 60 months following first patient enrollment
description: EFS is defined as the time from randomization to failure to achieve CR or CRi after remission induction, death after achieving CR or CRi or relapse after achieving CR or CRi, whichever occurs first. A patient is said to have failed to achieve CR or CRi after induction therapy, if his/her best response during or at completion of the induction treatment is less than CRi. Patients who achieved CR/CRi after remission induction and are not known to have relapsed or died will be censored at the date of last clinical assessment.
measure: Overall survival (OS)
time frame: Approximately up to 84 months following first patient enrollment
description: OS is defined as the time from date of randomization to date of death due to any cause. Patients still alive or lost to follow up will be censored at the time they were last known to be alive.
measure: Relapse-free survival (RFS) after CR/CRi
time frame: Approximately up to 60 months following first patient enrollment
description: RFS is defined as time from the date of achievement of CR/CRi until relapse or death from any cause, whichever comes first. Patients still in first CR/CRi and alive or lost to follow up will be censored at the date of last clinical assessment.
measure: Cumulative incidence of relapse (CIR) after CR/CRi
time frame: Approximately up to 60 months following first patient enrollment
description: CIR is measured from the date of achievement of CR/CRi until the date of relapse. Patients not known to have relapsed will be censored on the date of last clinical assessment. Patients who died without relapse will be counted as a competing cause of failure.
measure: Cumulative incidence of death (CID) after CR/CRi
time frame: Approximately up to 60 months following first patient enrollment
description: CID is measured from the date of achievement of CR/CRi until the date of death from any cause. Patients not known to have died will be censored on the date they were last known to be alive. Patients who experienced relapse in CR/CRi will be counted as competing cause of failure.
measure: Complete remission without minimal residual disease (CRMRD-) rate after induction cycle 2
time frame: Approximately up to 60 months following first patient enrollment
description: CRMRD- rate is defined as the percentage of patients who achieved CR or CRi with no evidence of MRD in bone marrow
measure: Frequency and severity of adverse events according to CTCAE version 5.0
time frame: Continuously throughout the study, starting from informed consent until 30 days following the last administration of any study drug
description: Adverse events will be evaluated using the National Cancer Institute's Common Terminology Criteria for AEs (CTCAE) version 5.0
measure: CR/CRi rates after induction cycle 1 and 2
time frame: Approximately up to 60 months following first patient enrollment
description: CR and CRi are determined by the Investigator based on the European LeukemiaNet (ELN2017) recommended response criteria
measure: CR/CRi rate after remission induction (i.e., CR or CRi as best response during or at completion of induction therapy)
time frame: Approximately up to 60 months following first patient enrollment
description: CR+CRi rate after remission induction is defined as the percentage of patients with best response of CR or CRi during or at completion of induction therapy
measure: Time to hematopoietic recovery after each chemotherapy treatment cycle
time frame: Approximately up to 60 months following first patient enrollment
description: Time to hematopoietic recovery is defined as the time from the start of the cycle until recovery
measure: EQ-5D-5L visual analogue scale (VAS)
time frame: At entry, 1st day of maintenance, every 3 months during the first year of maintenance, every 6 months during the second year of maintenance until relapse or treatment discontinuation (approximately up to 84 months following first patient enrollment)
description: The EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today". Each domain has 5 levels. Each level has a 1 digit number expressing the level selected for that dimension. These levels are summed up and the self-rated health is recorded on a 20 cm vertical, visual analogue scale, with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
measure: EORTC-QLQ-C30 global health status/QoL scale.
time frame: At entry, 1st day of maintenance, every 3 months during the first year of maintenance, every 6 months during the second year of maintenance until relapse or treatment discontinuation (approximately up to 84 months following first patient enrollment)
description: The EORTC QLQ-C30 is a 30-item questionnaire that assesses 5 functional subdomains (physical functioning, role functioning, emotional functioning, cognitive functioning and social functioning), 1 global health status, 3 symptom subdomains (fatigue, nausea and vomiting and pain) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Estimate the average of the items that contribute to the scale; this is the raw score. a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
arm group label: Arm A: Placebo
arm group type: Placebo Comparator
description: Cycle 1: day 1-start cycle 2 | Cycle 2: day 1 - start consolidation treatment | Consolidation treatment: day 1 - start maintenance | Maintenance treatment: day 1- day 730 (2 years) |
The dosage for Placebo for AG-120 (IDH1): 500 mg dose/day
The dosage for Placebo for AG-221 (IDH2): 100mg dose/day
arm group label: Arm B: Ivosidenib (IDH1) or Enasidenib (IDH2)
arm group type: Experimental
description: Cycle 1: day 1-start cycle 2 | Cycle 2: day 1 - start consolidation treatment | Consolidation treatment: day 1 - start maintenance | Maintenance treatment: day 1- day 730 (2 years) |
The dosage for AG-120 (IDH1): 500 mg dose/day
The dosage for AG-221 (IDH2): 100mg dose/day
intervention type: Drug
intervention name: AG-120
description: 250mg tablets
arm group label: Arm B: Ivosidenib (IDH1) or Enasidenib (IDH2)
other name: Ivosidenib
intervention type: Drug
intervention name: Placebo for AG-120
description: 250mg tablets
arm group label: Arm A: Placebo
intervention type: Drug
intervention name: AG-221
description: 100mg tablets
arm group label: Arm B: Ivosidenib (IDH1) or Enasidenib (IDH2)
other name: Enasidenib
intervention type: Drug
intervention name: Placebo for AG-221
description: 100mg tablets
arm group label: Arm A: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: B.J. Wouters
role: Principal Investigator
affiliation: Erasmus MC / HOVON
last name: B.J. Wouters, Dr.
phone: +31 10 704 15 60
email: b.wouters@erasmusmc.nl
last name: K. Doehner, Prof
phone: +49 731 500 45501
email: konstanze.doehner@uniklinik-ulm.de
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Withdrawn
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status: Recruiting
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status: Recruiting
country: Australia
country: Austria
country: Belgium
country: Estonia
country: Finland
country: France
country: Germany
country: Ireland
country: Lithuania
country: Luxembourg
country: Netherlands
country: Norway
country: Spain
country: Sweden
country: Switzerland
url: http://www.hovon.nl
description: HOVON website
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Preleukemia
mesh term: Myelodysplastic Syndromes
mesh term: Anemia, Refractory, with Excess of Blasts
mesh term: Syndrome
mesh term: Ivosidenib
mesh term: Glycine
sharing ipd: No