<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/NCT04506086</url>
  </required_header>
  <id_info>
    <org_study_id>20190014</org_study_id>
    <nct_id>NCT04506086</nct_id>
  </id_info>
  <brief_title>Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)</brief_title>
  <official_title>A Phase 4, Multi-center Open-label Feasibility Study to Evaluate Outpatient Blinatumomab Administration in Adult Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL) in Complete Hematologic Remission</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to determine the safety and feasibility of complete outpatient blinatumomab&#xD;
      administration for subjects with minimal/measurable residual disease (MRD) of B-precursor&#xD;
      Acute Lymphoblastic Leukemia (ALL).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 26, 2021</start_date>
  <completion_date type="Anticipated">December 28, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 28, 2025</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</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>Cycle 1: Incidence of grade 3 and/or 4 adverse events of special interest</measure>
    <time_frame>Day 1 to 3 of Cycle 1 (each cycle is 6 weeks)</time_frame>
    <description>Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cycle 2: Incidence of grade 3 and/or 4 adverse events of special interest</measure>
    <time_frame>Day 1 to 2 of Cycle 2 (each cycle is 6 weeks)</time_frame>
    <description>Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cycle 1: Incidence of any adverse events requiring hospitalization</measure>
    <time_frame>Day 1 to 3 of Cycle 1 (each cycle is 6 weeks)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cycle 2: Incidence of any adverse events requiring hospitalization</measure>
    <time_frame>Day 1 to 2 of Cycle 2 (each cycle is 6 weeks)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time (in minutes) from first onset of fever, hypotension, hypoxia, other grade 3 or 4 vital sign including seizure or neurological change (grade 3-limiting self-care activities of daily living to therapeutic intervention</measure>
    <time_frame>Day 1 to 3 of Cycle 1, and Day 1 to 2 of Cycle 2 (each cycle is 6 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment emergent Adverse events</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse events of Special interest</measure>
    <time_frame>Up to 6 Months</time_frame>
    <description>Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of treatment emergent adverse events</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The investigator will make an assessment of severity for each adverse event reported during the study. The assessment of severity will be based on the Common Terminology Criteria for Adverse Events version 5.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of adverse events of special interest</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).&#xD;
The investigator will make an assessment of severity for each adverse event reported during the study. The assessment of severity will be based on the Common Terminology Criteria for Adverse Events version 5.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30</measure>
    <time_frame>Prior to treatment on Day 1 of Cycle 1 and 2 (each cycle is 6 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment emergent adverse events that resulted in hospitalizations</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment emergent adverse events that resulted in surgeries</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment emergent adverse events that resulted in the use of concomitant medications</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment emergent adverse events that resulted in the use of device/procedure intervention.</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>B-precursor Acute Lymphoblastic Leukemia</condition>
  <arm_group>
    <arm_group_label>Blinatumomab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Blinatumomab</intervention_name>
    <description>Participants will receive blinatumomab continuous IV infusion for a maximum of 4 cycles. Each cycle is 6 weeks in duration consisting of 4 weeks of treatment and 2 weeks of rest.</description>
    <arm_group_label>Blinatumomab</arm_group_label>
    <other_name>AMG 103</other_name>
    <other_name>Blincyto</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Current Wearable Heatlth Monitoring System (CWHMS)</intervention_name>
    <description>The study will use the CWHMS device to monitor participants' vital signs while they are at home.</description>
    <arm_group_label>Blinatumomab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has provided informed consent prior to initiation of any study-specific&#xD;
             activities/procedures OR subject's legally acceptable representative has provided&#xD;
             informed consent prior to any study-specific activities/procedures being initiated&#xD;
             when the subject has any kind of condition that, in the opinion of the Investigator,&#xD;
             may compromise the ability of the subject to give written informed consent&#xD;
&#xD;
          -  Age greater than or equal to 18 years&#xD;
&#xD;
          -  B-cell precursor (BCP) acute lymphoblastic leukemia (ALL) with minimal/measurable&#xD;
             residual disease defined as hematologic complete remission (CR) with less than 5% bone&#xD;
             marrow blasts and meets clinical eligibility criteria to receive blinatumomab as&#xD;
             outlined below.&#xD;
&#xD;
          -  Hematologic criteria for remission as defined below:&#xD;
&#xD;
               -  Less than 5% bone marrow blasts&#xD;
&#xD;
               -  Absolute neutrophil count greater than or equal to 1.0 x10^9 L&#xD;
&#xD;
               -  Platelets greater than or equal to 50 x10^9/L (transfusion permitted)&#xD;
&#xD;
               -  Hemoglobin level greater than or equal to 90 g/L (transfusion permitted)&#xD;
&#xD;
          -  Renal and hepatic function as defined below:&#xD;
&#xD;
          -  Total bilirubin &lt;3 x upper limit of normal (ULN) unless related to Gilbert's or&#xD;
             Meulengracht disease&#xD;
&#xD;
          -  Serum creatinine &lt;1.5 x ULN. If serum creatinine ≥1.5 x ULN, then measure Glomerular&#xD;
             Filtration Rate (GFR); subject will be eligible only if measured GFR is within normal&#xD;
             limits.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1&#xD;
&#xD;
          -  Negative pregnancy test in women of childbearing potential&#xD;
&#xD;
          -  Ability and willingness to wear and comply with the instructions for the use of and&#xD;
             monitoring of the digital monitoring devices as outlined in informed consent&#xD;
&#xD;
          -  Subject resides within 1 hour of ground transportation to an advanced medical care&#xD;
             facility for the duration of the mandatory device monitoring period (MDMP)&#xD;
&#xD;
          -  Adequate cellular service available during MDMP.&#xD;
&#xD;
          -  Presence of an adult (greater than or equal to 18 years) caregiver(s) in the same&#xD;
             dwelling, for 24 hours/day for the entire MDMP. Caregiver will be expected to have&#xD;
             access to transportation&#xD;
&#xD;
          -  Ability and willingness to participate in the health management of the subject and to&#xD;
             assist with the requirements of remote digital monitoring devices during the&#xD;
             blinatumomab infusion within the MDMP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of circulating blasts&#xD;
&#xD;
          -  Presence of extramedullary disease&#xD;
&#xD;
          -  History of relevant central nervous system (CNS) pathology or current relevant CNS&#xD;
             pathology (seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe&#xD;
             brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain&#xD;
             syndrome, psychosis, or coordination or movement disorders&#xD;
&#xD;
          -  Current infiltration of cerebrospinal fluid (CSF) by ALL. If screening cerebrospinal&#xD;
             fluid (CSF) demonstrates leukemic blasts, subjects must receive intrathecal treatment&#xD;
             and demonstrate negative CSF before enrollment and starting blinatumomab infusion&#xD;
&#xD;
          -  Current autoimmune disease or history of autoimmune disease with potential CNS&#xD;
             involvement&#xD;
&#xD;
          -  Allogeneic hematopoietic stem cell transplantation (HSCT) within 12 weeks before&#xD;
             blinatumomab treatment&#xD;
&#xD;
          -  Active acute or chronic graft versus host disease (GvHD) requiring systemic treatment&#xD;
             with immunosuppressive medication&#xD;
&#xD;
          -  Systemic chemotherapy within 2 weeks prior to study treatment (except for intrathecal&#xD;
             prophylaxis)&#xD;
&#xD;
          -  Radiotherapy within 4 weeks prior to study treatment&#xD;
&#xD;
          -  Known hypersensitivity to blinatumomab or to any component of the product formulation&#xD;
&#xD;
          -  Active malignancy other than ALL with the exception of basal cell or squamous cell&#xD;
             carcinoma of the skin, or carcinoma in situ of the cervix&#xD;
&#xD;
          -  History of other malignancy within the past 2 years, with the following exception[s]:&#xD;
&#xD;
               -  Malignancy treated with curative intent and with no known active disease present&#xD;
                  for greater than or equal to 2 years before enrollment and felt to be at low risk&#xD;
                  for recurrence by the treating physician&#xD;
&#xD;
               -  Adequately treated non-melanoma skin cancer or lentigo maligna without evidence&#xD;
                  of disease&#xD;
&#xD;
               -  Adequately treated cervical carcinoma in situ without evidence of disease&#xD;
&#xD;
               -  Adequately treated breast ductal carcinoma in situ without evidence of disease&#xD;
&#xD;
               -  Prostatic intraepithelial neoplasia without evidence of prostate cancer&#xD;
&#xD;
               -  Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in&#xD;
                  situ&#xD;
&#xD;
          -  Currently receiving treatment with an investigational device or drug study or less&#xD;
             than 30 days since ending treatment on an investigational device or drug study(ies)&#xD;
&#xD;
          -  Active uncontrolled infection requiring therapy&#xD;
&#xD;
          -  Known infection or chronic infection with hepatitis B virus (hepatitis B surface&#xD;
             antigen [HBsAg] positive) or hepatitis C virus (HCV) (anti-HCV positive)&#xD;
&#xD;
          -  Known positive test for human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Any concurrent disease or medical condition deemed to interfere with the conduct of&#xD;
             the study and remote digital monitoring as judged by the investigator&#xD;
&#xD;
          -  Any acutely ill cardiac patients with the potential to develop life threatening&#xD;
             arrhythmias eg, very fast atrial fibrillation&#xD;
&#xD;
          -  Subjects with no cellular signal in their home&#xD;
&#xD;
          -  Subjects with bi-lateral upper arm tattoos directly under the area of Current Wearable&#xD;
             Health Monitoring System (CWHMS) application (Current Health wearable device)&#xD;
&#xD;
          -  Subjects with a known allergy to any of the device component materials&#xD;
&#xD;
          -  Subjects with open wounds on both arms directly under the area of CWHMS application&#xD;
             (Current Health wearable device) or with injuries to both arms&#xD;
&#xD;
          -  Subjects with an upper arm circumference of less than 20 cm or greater than 50 cm&#xD;
&#xD;
          -  Subjects with an implantable defibrillator&#xD;
&#xD;
          -  Subjects unwilling to wear the CWHMS (Current Health wearable device, axillary&#xD;
             temperature patch) during the mandatory monitoring period (MDMP) in cycles 1 and 2&#xD;
&#xD;
          -  Subjects with excessive scarring directly under the area of CWHMS (Current Health&#xD;
             wearable device) application&#xD;
&#xD;
          -  Subjects who cannot have their blood pressure (BP) measured in both arms (or wrists)&#xD;
             eg due to atrio-venous shunt, risk of lymphedema or peripherally inserted central&#xD;
             catheter line&#xD;
&#xD;
          -  Female subject is pregnant or breastfeeding or planning to become pregnant or&#xD;
             breastfeed during treatment and for an additional 48 hours after the last dose of&#xD;
             protocol-specified therapy&#xD;
&#xD;
          -  Female subjects of childbearing potential unwilling to use 1 highly effective method&#xD;
             of contraception during treatment and for an additional 48 hours after the last dose&#xD;
             of protocol-specified therapy Refer to Section 11.5 for additional contraceptive&#xD;
             information&#xD;
&#xD;
          -  Female subjects of childbearing potential with a positive pregnancy test assessed at&#xD;
             Screening by a serum pregnancy test and/or urine pregnancy test&#xD;
&#xD;
          -  Subject likely to not be available to complete all protocol-required study visits or&#xD;
             procedures, and/or to comply with all required study procedures (eg, patient reported&#xD;
             outcomes [PROs]) to the best of the subject and investigator's knowledge&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amgen Call Center</last_name>
    <phone>866-572-6436</phone>
    <email>medinfo@amgen.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>City of Hope National Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of California Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of California Irvine</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868-3201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Advocate Lutheran General Hospital</name>
      <address>
        <city>Park Ridge</city>
        <state>Illinois</state>
        <zip>60068</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Rochester Cancer Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Comprehensive Cancer Research Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Saint Francis Hospital, Inc</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29607</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health System</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Blinatumomab</keyword>
  <keyword>Leukemia</keyword>
  <keyword>Acute lymphoblastic leukemia</keyword>
  <keyword>B-precursor Acute Lymphoblastic Leukemia</keyword>
  <keyword>Minimal/Measurable Residual Disease</keyword>
  <keyword>Bi-specific T-cell engager</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Neoplasm, Residual</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Blinatumomab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.</ipd_access_criteria>
    <ipd_url>https://www.amgen.com/datasharing</ipd_url>
  </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/NCT04506086
org study id: 20190014
nct id: NCT04506086
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
The study aims to determine the safety and feasibility of complete outpatient blinatumomab
      administration for subjects with minimal/measurable residual disease (MRD) of B-precursor
      Acute Lymphoblastic Leukemia (ALL).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cycle 1: Incidence of grade 3 and/or 4 adverse events of special interest
time frame: Day 1 to 3 of Cycle 1 (each cycle is 6 weeks)
description: Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).
measure: Cycle 2: Incidence of grade 3 and/or 4 adverse events of special interest
time frame: Day 1 to 2 of Cycle 2 (each cycle is 6 weeks)
description: Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).
measure: Cycle 1: Incidence of any adverse events requiring hospitalization
time frame: Day 1 to 3 of Cycle 1 (each cycle is 6 weeks)
measure: Cycle 2: Incidence of any adverse events requiring hospitalization
time frame: Day 1 to 2 of Cycle 2 (each cycle is 6 weeks)
measure: Time (in minutes) from first onset of fever, hypotension, hypoxia, other grade 3 or 4 vital sign including seizure or neurological change (grade 3-limiting self-care activities of daily living to therapeutic intervention
time frame: Day 1 to 3 of Cycle 1, and Day 1 to 2 of Cycle 2 (each cycle is 6 weeks)
measure: Incidence of treatment emergent Adverse events
time frame: Up to 6 months
measure: Incidence of Adverse events of Special interest
time frame: Up to 6 Months
description: Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).
measure: Severity of treatment emergent adverse events
time frame: Up to 6 months
description: The investigator will make an assessment of severity for each adverse event reported during the study. The assessment of severity will be based on the Common Terminology Criteria for Adverse Events version 5.0.
measure: Severity of adverse events of special interest
time frame: Up to 6 months
description: Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).
The investigator will make an assessment of severity for each adverse event reported during the study. The assessment of severity will be based on the Common Terminology Criteria for Adverse Events version 5.0.
measure: Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
time frame: Prior to treatment on Day 1 of Cycle 1 and 2 (each cycle is 6 weeks)
measure: Incidence of treatment emergent adverse events that resulted in hospitalizations
time frame: Up to 6 months
measure: Incidence of treatment emergent adverse events that resulted in surgeries
time frame: Up to 6 months
measure: Incidence of treatment emergent adverse events that resulted in the use of concomitant medications
time frame: Up to 6 months
measure: Incidence of treatment emergent adverse events that resulted in the use of device/procedure intervention.
time frame: Up to 6 months
arm group label: Blinatumomab
arm group type: Experimental
intervention type: Drug
intervention name: Blinatumomab
description: Participants will receive blinatumomab continuous IV infusion for a maximum of 4 cycles. Each cycle is 6 weeks in duration consisting of 4 weeks of treatment and 2 weeks of rest.
arm group label: Blinatumomab
other name: AMG 103
other name: Blincyto
intervention type: Device
intervention name: Current Wearable Heatlth Monitoring System (CWHMS)
description: The study will use the CWHMS device to monitor participants' vital signs while they are at home.
arm group label: Blinatumomab
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
last name: Amgen Call Center
phone: 866-572-6436
email: medinfo@amgen.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: United States
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
mesh term: Neoplasm, Residual
mesh term: Blinatumomab
sharing ipd: Yes
ipd description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
ipd access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
ipd url: https://www.amgen.com/datasharing