<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/NCT03236857</url>
  </required_header>
  <id_info>
    <org_study_id>M13-833</org_study_id>
    <secondary_id>2017-000439-14</secondary_id>
    <nct_id>NCT03236857</nct_id>
  </id_info>
  <brief_title>A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies</brief_title>
  <official_title>A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roche-Genentech</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AbbVie</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of&#xD;
      venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended&#xD;
      Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and&#xD;
      young adult participants with relapsed or refractory malignancies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 8, 2017</start_date>
  <completion_date type="Actual">April 19, 2023</completion_date>
  <primary_completion_date type="Actual">April 19, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Experiencing Adverse Events</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Dose Limiting Toxicities (DLT) of Venetoclax Monotherapy</measure>
    <time_frame>First 21 days venetoclax monotherapy</time_frame>
    <description>A DLT is any Grade 3 or higher non-hematologic adverse event (AE) with exceptions outlined in the protocol.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recommended Phase 2 dose (RPTD) of Venetoclax</measure>
    <time_frame>First 21 days venetoclax monotherapy</time_frame>
    <description>Venetoclax RPTD is the dose determined based on adverse event reporting and dose-limiting toxicity information from all participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Venetoclax</measure>
    <time_frame>Up to approximately 2 weeks</time_frame>
    <description>Maximum plasma concentration (Cmax) of venetoclax.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of venetoclax</measure>
    <time_frame>Up to approximately 2 weeks</time_frame>
    <description>Time to maximum plasma concentration (Tmax) of venetoclax.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-24 Post-Dose of Venetoclax</measure>
    <time_frame>Up to approximately 2 weeks</time_frame>
    <description>Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>ORR is defined as the proportion of participants who achieved a response according to established criteria described in detail in the study protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial Response (PR) Rate</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>PR is defined according to established criteria for each tumor type and is described in detail within the study protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Response (CR) Rate</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>CR is defined according to established criteria for each tumor type and is described in detail within the study protocol.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">143</enrollment>
  <condition>Malignancies</condition>
  <condition>Acute Lymphoblastic Leukemia (ALL)</condition>
  <condition>Acute Myeloid Leukemia (AML)</condition>
  <condition>Non-Hodgkin's Lymphoma</condition>
  <condition>Neuroblastoma</condition>
  <arm_group>
    <arm_group_label>Venetoclax with or without chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Venetoclax administered orally once daily (QD) with various doses and dosing regimens with or without chemotherapy at the discretion of the investigator. Allowed chemotherapy regimens as outlined in the study protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>chemotherapy</intervention_name>
    <description>Dexamethasone and/or vincristine and/or pegasparaginase OR cytarabine and/or etoposide and/or pegasparaginase; tyrosine kinase inhibitor; cytarabine OR azacitidine OR decitabine; rituximab and/or dexamethasone and/or vincristine; cyclophosphamide and/or topotecan</description>
    <arm_group_label>Venetoclax with or without chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>venetoclax</intervention_name>
    <description>Oral tablet for participants; Tablet for oral suspension (participants who cannot swallow a tablet)</description>
    <arm_group_label>Venetoclax with or without chemotherapy</arm_group_label>
    <other_name>ABT-199</other_name>
    <other_name>GDC-0199</other_name>
    <other_name>Venclexta</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have relapsed or refractory cancer.&#xD;
&#xD;
          -  Participants must have adequate hepatic and kidney function.&#xD;
&#xD;
          -  Participants less than or equal to 16 years of age must have performance status of&#xD;
             Lansky greater than or equal to 50% and participants greater than 16 years of age must&#xD;
             have performance status of Karnofsky greater than or equal to 50%.&#xD;
&#xD;
          -  Participants with solid tumors (with the exception of neuroblastoma) must have&#xD;
             adequate bone marrow function in Part 1.&#xD;
&#xD;
          -  For the fifth cohort during Part 2 Cohort Expansion, participants with solid tumors&#xD;
             must have evidence of BCL-2 expression (except participants with TCF3-HLF ALL).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with primary brain tumors or disease metastatic to the brain.&#xD;
&#xD;
          -  Participants who have central nervous system (CNS) disease with cranial involvement&#xD;
             that requires radiation.&#xD;
&#xD;
          -  Participants who have received any of the following within the listed time frame,&#xD;
             prior to the first dose of study drug&#xD;
&#xD;
               -  Inotuzumab ozogamicin or gemtuzumab ozogamicin within 30 days&#xD;
&#xD;
               -  Biologic agent (i.e., antibodies) for anti-neoplastic intent within 30 days or 5&#xD;
                  half-lives whichever is shorter.&#xD;
&#xD;
               -  CAR-T infusion or other cellular therapy within 30 days&#xD;
&#xD;
               -  Anticancer therapy including chemotherapy, radiation therapy, targeted small&#xD;
                  molecule agents, investigational agents within 14 days or 5 half-lives, whichever&#xD;
                  is shorter (Exceptions: Ph+ALL participants on Tyrosine Kinase Inhibitor (TKI) at&#xD;
                  Screening may enroll and remain on TKI therapy to control disease and TCF3-HLF&#xD;
                  ALL participants are allowed to have received chemotherapy within 14 days or 5&#xD;
                  half-lives, whichever is shorter).&#xD;
&#xD;
               -  Steroid therapy for anti-neoplastic intent within 5 days (with the exception of&#xD;
                  TCF3-HLF ALL participants).&#xD;
&#xD;
               -  Requires ongoing hydroxyurea (hydroxyurea permitted up to first dose)&#xD;
&#xD;
          -  Participants who are less than 100 days post-transplant, or greater than or equal to&#xD;
             100 days post-transplant with active graft versus host disease (GVHD), or are&#xD;
             receiving immunosuppressant therapy within 7 days prior to first dose of study drug.&#xD;
&#xD;
          -  Participants who are less than 6 weeks post-131 I-metaiodobenzylguanidine (mIBG)&#xD;
             therapy.&#xD;
&#xD;
          -  Participants who have received the following within 7 days prior to the first dose of&#xD;
             study drug:&#xD;
&#xD;
               -  Strong and moderate Cytochrome P450 3A (CYP3A) inhibitors (Part 1 Dose&#xD;
                  Determination);&#xD;
&#xD;
               -  Strong and moderate CYP3A inducers (Part 1 Dose Determination and Part 2 Cohort&#xD;
                  Expansion).&#xD;
&#xD;
          -  Participants who have not recovered from clinically significant adverse&#xD;
             effect(s)/toxicity(s) of the previous therapy (Exception: Chemotherapy induced side&#xD;
             effects that are expected to return to baseline in TCF3-HLF ALL participants).&#xD;
&#xD;
          -  Participants who have active, uncontrolled infections.&#xD;
&#xD;
          -  Participants with malabsorption syndrome or any other condition that precludes enteral&#xD;
             administration.&#xD;
&#xD;
               -  Participants with recent positive test for SARS-CoV-2 (COVID-19) and no follow up&#xD;
                  test with negative result cannot be enrolled. Participants with contact to&#xD;
                  persons with COVID-19 and participants with signs and symptoms for COVID-19&#xD;
                  infection must be tested before enrolling.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Univ California, San Francisco /ID# 163460</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143-2204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Colorado /ID# 161551</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Healthcare of Atlan /ID# 161552</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute /ID# 163440</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center-Koch Center /ID# 163444</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065-6007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital /ID# 161550</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia /ID# 163445</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Jude Children's Research Hospital /ID# 163447</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Children's /ID# 164399</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital /ID# 163459</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin /ID# 163461</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226-3522</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sydney Children's Hospital /ID# 163148</name>
      <address>
        <city>Randwick</city>
        <state>New South Wales</state>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queensland Children's Hospital /ID# 163146</name>
      <address>
        <city>South Brisbane</city>
        <state>Queensland</state>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women and Childrens Hospital /ID# 163147</name>
      <address>
        <city>North Adelaide</city>
        <state>South Australia</state>
        <zip>5006</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Children's Hospital /ID# 163104</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for Sick Children /ID# 163726</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Sainte-Justine /ID# 163725</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HM - Hopital de la Timone /ID# 161465</name>
      <address>
        <city>Marseille CEDEX 05</city>
        <state>Bouches-du-Rhone</state>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Leon Berard /ID# 163707</name>
      <address>
        <city>Lyon CEDEX 08</city>
        <state>Rhone</state>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HP - Hopital Armand-Trousseau /ID# 163728</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Robert Debre Hopital, FR /ID# 161464</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse - Hôpital des enfants /ID# 163727</name>
      <address>
        <city>Toulouse CEDEX 9</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Freiburg /ID# 164206</name>
      <address>
        <city>Freiburg</city>
        <state>Baden-Wuerttemberg</state>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 161729</name>
      <address>
        <city>Kiel</city>
        <state>Schleswig-Holstein</state>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 161730</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Essen /ID# 164207</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC - Sophia /ID# 161579</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 GD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prinses Maxima Centrum /ID# 162670</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CS</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kinderspital Zurich - Eleonorenstiftung /ID# 163037</name>
      <address>
        <city>Zurich</city>
        <state>Zuerich</state>
        <zip>8032</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Ormond Street Hospital for Children /ID# 169238</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>WC1N 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 162938</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>May 19, 2023</last_update_submitted>
  <last_update_submitted_qc>May 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Venetoclax</keyword>
  <keyword>pediatric</keyword>
  <keyword>relapsed or refractory</keyword>
  <keyword>Venclexta</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Neuroblastoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Venetoclax</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/NCT03236857
org study id: M13-833
secondary id: 2017-000439-14
nct id: NCT03236857
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of
      venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended
      Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and
      young adult participants with relapsed or refractory malignancies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Experiencing Adverse Events
time frame: Up to 9 months
description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
measure: Number of Participants With Dose Limiting Toxicities (DLT) of Venetoclax Monotherapy
time frame: First 21 days venetoclax monotherapy
description: A DLT is any Grade 3 or higher non-hematologic adverse event (AE) with exceptions outlined in the protocol.
measure: Recommended Phase 2 dose (RPTD) of Venetoclax
time frame: First 21 days venetoclax monotherapy
description: Venetoclax RPTD is the dose determined based on adverse event reporting and dose-limiting toxicity information from all participants.
measure: Cmax of Venetoclax
time frame: Up to approximately 2 weeks
description: Maximum plasma concentration (Cmax) of venetoclax.
measure: Tmax of venetoclax
time frame: Up to approximately 2 weeks
description: Time to maximum plasma concentration (Tmax) of venetoclax.
measure: AUC0-24 Post-Dose of Venetoclax
time frame: Up to approximately 2 weeks
description: Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax.
measure: Objective Response Rate (ORR)
time frame: Up to 9 months
description: ORR is defined as the proportion of participants who achieved a response according to established criteria described in detail in the study protocol.
measure: Partial Response (PR) Rate
time frame: Up to 9 months
description: PR is defined according to established criteria for each tumor type and is described in detail within the study protocol.
measure: Complete Response (CR) Rate
time frame: Up to 9 months
description: CR is defined according to established criteria for each tumor type and is described in detail within the study protocol.
arm group label: Venetoclax with or without chemotherapy
arm group type: Experimental
description: Venetoclax administered orally once daily (QD) with various doses and dosing regimens with or without chemotherapy at the discretion of the investigator. Allowed chemotherapy regimens as outlined in the study protocol.
intervention type: Drug
intervention name: chemotherapy
description: Dexamethasone and/or vincristine and/or pegasparaginase OR cytarabine and/or etoposide and/or pegasparaginase; tyrosine kinase inhibitor; cytarabine OR azacitidine OR decitabine; rituximab and/or dexamethasone and/or vincristine; cyclophosphamide and/or topotecan
arm group label: Venetoclax with or without chemotherapy
intervention type: Drug
intervention name: venetoclax
description: Oral tablet for participants; Tablet for oral suspension (participants who cannot swallow a tablet)
arm group label: Venetoclax with or without chemotherapy
other name: ABT-199
other name: GDC-0199
other name: Venclexta
criteria: 
gender: All
minimum age: 0 Years
maximum age: 25 Years
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
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country: Australia
country: Canada
country: France
country: Germany
country: Netherlands
country: Switzerland
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid, Acute
mesh term: Neoplasms
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Neuroblastoma
mesh term: Venetoclax
sharing ipd: No