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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04994717
Registration number
NCT04994717
Ethics application status
Date submitted
30/07/2021
Date registered
6/08/2021
Titles & IDs
Public title
Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia
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Scientific title
Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)
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Secondary ID [1]
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2020-004498-29
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Secondary ID [2]
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20190360
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Blinatumomab
Treatment: Drugs - Low-intensity chemotherapy regimen
Treatment: Drugs - SOC chemotherapy regimen
Experimental: Safety Run-in: Blinatumomab alternating with low-intensity chemotherapy - The safety run-in will be performed prior to initiating the phase 3 randomized part of the study. This safety run-in is to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy.
The safety run-in also evaluates a shorter dose step interval from (4 days instead of 7 days) and a 1-week (instead of 2-week) drug free interval between blinatumomab cycles. Blinatumomab will be infused at a lower dose for 4 days and increase to a higher dose on Day 5 of the infusion for the remainder of the infusion.
Experimental: Phase 3: Blinatumomab alternating with low-intensity chemotherapy - Participants will receive blinatumomab alternating with low-intensity chemotherapy.
Active comparator: Phase 3: Standard of care (SOC) chemotherapy - Participants will receive 1 of 2 SOC chemotherapy regimens (GMALL or HyperCVAD) per investigator's choice.
Treatment: Drugs: Blinatumomab
Continuous intravenous (cIV) infusion
Treatment: Drugs: Low-intensity chemotherapy regimen
Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.
Treatment: Drugs: SOC chemotherapy regimen
Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety run-in: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
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Assessment method [1]
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Number and percentage of participants who experience one or more TEAE, serious TEAE, treatment-related adverse events, and adverse events of interest.
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Timepoint [1]
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Up to approximately 5 years
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Primary outcome [2]
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Phase 3: Event-free Survival (EFS)
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Assessment method [2]
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Time from randomization (enrollment) until treatment failure, relapse or death from any cause, whichever is earlier.
Treatment failure is defined as not achieving a hematological complete CR with MRD response \<10-4 by the end of the initial disease assessment period.
Relapse is defined as hematologic relapse, extramedullary relapse, and/or molecular relapse (MRD positivity \>= 10\^-3), whichever occurs earlier, in participants with prior achievement of hematologic CR with MRD response \<10\^-4.
Participants without an event will be censored at their last evaluable disease assessment date.
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Timepoint [2]
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Up to approximately 5 years
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Primary outcome [3]
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Phase 3: Overall Survival (OS)
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Assessment method [3]
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OS is defined as time from randomization (enrollment) until death due to any cause.
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Timepoint [3]
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Up to approximately 5 years
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Secondary outcome [1]
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Safety run-in: Complete Remission (CR) Rate by the End of Initial Disease Assessment Period
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Assessment method [1]
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Timepoint [1]
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Baseline to Week 14
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Secondary outcome [2]
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Safety run-in: Minimal Residual Disease (MRD) Response by the End of Initial Disease Assessment Period
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Assessment method [2]
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MRD response is defined as the percentage of participants who achieve a response of \< 10\^-4 measured by polymerase chain reaction (PCR).
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Timepoint [2]
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Baseline to Week 14
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Secondary outcome [3]
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Safety run-in: Relapse-free Survival (RFS)
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Assessment method [3]
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RFS: In participants who achieve CR, the time from first achievement of this response until date of the first relapse including hematologic relapse, extramedullary relapse, or death due to any cause, whichever occurs first.
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Timepoint [3]
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Up to approximately 5 years
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Secondary outcome [4]
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Safety run-in: Minimal Residual Disease (MRD) Relapse Free Survival (RFS)
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Assessment method [4]
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MRD RFS: In participants who achieve CR with MRD response, the time from first achievement of this response until date of of the first relapse including molecular relapse, hematological relapse, and/or extramedullary relapse, or death due to any cause, whichever occurs first. (Molecular relapse will be defined 2 ways: MRD\>= 10\^-3 and MRD\>=10\^-4. Participants without an event will be censored at their last evaluable disease assessment date.
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Timepoint [4]
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Up to approximately 5 years
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Secondary outcome [5]
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Safety run-in: Steady State Concentration (Css) of Blinatumomab
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Assessment method [5]
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Timepoint [5]
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Up to approximately 34 weeks
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Secondary outcome [6]
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Safety run-in: Clearance (CL) of Blinatumomab
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Assessment method [6]
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Timepoint [6]
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Up to approximately 34 weeks
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Secondary outcome [7]
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Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Fatigue Score
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Assessment method [7]
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Fatigue score will be measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 7a.
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Timepoint [7]
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Baseline to Week 14
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Secondary outcome [8]
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Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Pain Score
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Assessment method [8]
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Pain score will be measured by Brief Pain Inventory - Short Form (BPI-SF); Item 3: pain at its worst in the last 24 hours.
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Timepoint [8]
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Baseline to Week 14
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Secondary outcome [9]
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Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Global Health Status
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Assessment method [9]
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Global health status will be measured by the Quality of Life Questionnaire (QLQ)-C30 global health status quality of life scale.
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Timepoint [9]
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Baseline to Week 14
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Secondary outcome [10]
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Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Physical Function
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Assessment method [10]
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Physical function will be measured by the QLQ-C30 functional scale.
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Timepoint [10]
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Baseline to Week 14
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Secondary outcome [11]
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Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Nausea and Vomiting
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Assessment method [11]
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Nausea and vomiting will be measured by the QLQ-C30 symptom scale.
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Timepoint [11]
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Baseline to Week 14
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Secondary outcome [12]
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Phase 3: Complete Remission (CR) Rate by the End of Initial Disease Assessment Period
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Assessment method [12]
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Timepoint [12]
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Baseline to Week 14
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Secondary outcome [13]
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Phase 3: Minimal Residual Disease (MRD) Response by the End of Initial Disease Assessment Period
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Assessment method [13]
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MRD response is defined as the percentage of participants who achieve a response of \< 10\^4 measured by polymerase chain reaction (PCR).
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Timepoint [13]
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Baseline to Week 14
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Secondary outcome [14]
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Phase 3: Relapse-free Survival (RFS)
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Assessment method [14]
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RFS: In participants who achieve CR, the time from first achievement of this response until the date of the first relapse including hematologic relapse, extra medullary relapse, or death due to any cause, whichever occurs first. Participants without an event will be censored at their last evaluable disease assessment date.
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Timepoint [14]
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Up to approximately 5 years
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Secondary outcome [15]
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Phase 3: Minimal Residual Disease (MRD) Relapse Free Survival (RFS)
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Assessment method [15]
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In participants who achieve CR with MRD response, the time from first achievement of this response until date of the first relapse including molecular relapse, hematologic relapse, and/or extramedullary relapse, or death due to any cause, whichever occurs first. Molecular relapse will be defined 2 ways: MRD\>= 10\^-3 and MRD\>= 10\^-4. Participants without an event will be censored at their last evaluable disease assessment date
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Timepoint [15]
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Up to approximately 5 years
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Secondary outcome [16]
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Phase 3: Minimal Residual Disease (MRD) Over Time
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Assessment method [16]
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Timepoint [16]
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Up to approximately 5 years
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Secondary outcome [17]
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Phase 3: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
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Assessment method [17]
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Number and percentage of participants who experience one or more TEAE, serious TEAE, treatment-related adverse events, and adverse events of interest.
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Timepoint [17]
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Up to approximately 5 years
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Secondary outcome [18]
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Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse by Flow Cytometry for Bone Marrow
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Assessment method [18]
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Timepoint [18]
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Up to approximately 5 years
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Secondary outcome [19]
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Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse Identified by Immunohistochemistry or Flow Cytometry for Cerebrospinal Fluid
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Assessment method [19]
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Timepoint [19]
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Up to end of safety follow up (approximately 44 months)
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Secondary outcome [20]
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Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse for Extramedullary Sites other than Cerebrospinal Fluid
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Assessment method [20]
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0
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Timepoint [20]
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Up to end of safety follow up (approximately 44 months)
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Secondary outcome [21]
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Phase 3: Rate of Lineage Switch to Acute Myeloid Leukemia (AML)
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Assessment method [21]
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0
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Timepoint [21]
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Up to end of safety follow up (approximately 44 months)
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Secondary outcome [22]
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Phase 3: Localization of Relapse by Clinical Assessment
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Assessment method [22]
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Timepoint [22]
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Up to end of safety follow up (approximately 44 months)
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Secondary outcome [23]
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Phase 3: Mortality Rate in Participants who Experience Complete Remission (CR)
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Assessment method [23]
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Timepoint [23]
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Up to approximately 5 years
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Secondary outcome [24]
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Phase 3: Number of Participants who have Allogeneic Hematopoietic Stem Cell Transplant (alloHSCT) in Participants who Experience Continuous First Complete Remission (CR)
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Assessment method [24]
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Timepoint [24]
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Up to approximately 5 years
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Secondary outcome [25]
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Phase 3: Mortality Rate in Participants who Experience Complete Remission (CR) after Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
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Assessment method [25]
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Timepoint [25]
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Up to approximately 5 years
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Secondary outcome [26]
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Phase 3: Relapse Rate Following Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
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Assessment method [26]
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Timepoint [26]
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Up to approximately 5 years
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Secondary outcome [27]
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Phase 3: Time to Deterioration using the Fatigue Score
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Assessment method [27]
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Fatigue score will be measured by PROMIS Fatigue-Short Form 7a.
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Timepoint [27]
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Up to approximately 5 years
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Secondary outcome [28]
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Phase 3: Time to Improvements using the Fatigue Score
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Assessment method [28]
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Fatigue score will be measured by PROMIS Fatigue-Short Form 7a.
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Timepoint [28]
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Up to approximately 5 years
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Secondary outcome [29]
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Phase 3: Time to Deterioration using the Pain Score
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Assessment method [29]
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Pain score will be measured by BPI-SF; Item 3: pain at its worst in the last 24 hours.
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Timepoint [29]
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Up to approximately 5 years
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Secondary outcome [30]
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Phase 3: Time to Improvements using the Pain Score
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Assessment method [30]
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Pain score will be measured by BPI-SF; Item 3: pain at its worst in the last 24 hours.
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Timepoint [30]
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Up to approximately 5 years
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Secondary outcome [31]
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Phase 3: Change from Baseline in Global Health Status, Physical Function, Nausea/Vomiting, and All Other Subscales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
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Assessment method [31]
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EORTC QLQ-C30 will include global health status, physical functioning, emotional functioning, cognitive functioning, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, diarrhea, and financial difficulties will be measured by EORTC QLQ-C30.
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Timepoint [31]
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Baseline to end of study (up to approximately 5 years)
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Secondary outcome [32]
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Phase 3: Time to Deterioration for Global Health Status, Physical Function, Nausea/Vomiting, and All Other Subscales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
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Assessment method [32]
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Global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, diarrhea, and financial difficulties will be measured by EORTC QCQ-C30.
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Timepoint [32]
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Up to approximately 5 years
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Secondary outcome [33]
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Phase 3: Time to Improvements for Global Health Status, Physical Function, Nausea/Vomiting, and All Other Subscales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
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Assessment method [33]
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Global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, diarrhea, and financial difficulties will be measured by EORTC QCQ-C30.
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Timepoint [33]
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Up to approximately 5 years
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Eligibility
Key inclusion criteria
- Age = 55 years at the time of informed consent. OR
Age 40 to < 55 years of age if at least 1 of the following comorbidities at the time of informed consent:
* history of grades 3 and 4 pancreatitis
* diabetes mellitus with end-organ damage
* severe liver disease such as cirrhosis stage 2 with portal hypertension or history of esophageal variceal bleeding and aspartate transaminase (AST)/alanine aminotransferase (ALT) > 10 x upper limit of normal (ULN) (liver cirrhosis must be confirmed by biopsy)
* body mass index (BMI) = 40 combined with relevant comorbidities such as metabolic syndrome
* Any further combination of documented severe comorbidities that the investigator judges to be incompatible with administering an intensive pediatric based, adult adapted standard chemotherapy regimen but still compatible with the suggested protocol for older participants in both the experimental and the SOC arm. The participant history will be reviewed by the medical monitor during screening to determine enrollment acceptability based on a standard list with types of comorbidities allowed. A medical advisory board is available to the investigators for questions/advice and includes experts in the field of adult leukemia with experience with the use of blinatumomab, the global development lead for blinatumomab and the medical monitor of the study.
* Participants with newly diagnosed Philadelphia (Ph)-negative B-cell precursor acute lymphoblastic leukemia (ALL)
* Eastern Cooperative Oncology Group (ECOG) performance status = 2, higher ECOG score allowed if due to underlying leukemia
* All participants must have adequate organ function as defined below:
* renal: estimated glomerular filtration rate based on MDRD calculation = 50 mL/min/1.73 m^2
* liver function: total bilirubin = 2x upper limit of normal (ULN; unless Gilbert's Disease or if liver involvement with leukemia); exception for participants 40 to < 55 years of age if they have a comorbidity listed above: severe liver disease such as cirrhosis stage 2 with portal hypertension or history of esophageal variceal bleeding and AST/ALT > 10 x ULN (liver cirrhosis must be confirmed by biopsy)
* cardiac: left ventricular ejection fraction (LVEF) = 50%
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Minimum age
40
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Active central nervous system (CNS) leukemia not resolved with IT chemotherapy during screening.
* Clinically relevant CNS pathology requiring treatment (eg, unstable epilepsy).
* Current autoimmune disease or history of autoimmune disease with potential CNS involvement
* Known infection with human immunodeficiency virus (HIV)
* Known infection with chronic or active infection with hepatitis B (eg, hepatitis b surface [HBs] antigen reactive or quantifiable hepatitis b virus [HBV] viral load) or hepatitis C virus (HCV) (eg, HCV RNA [qualitative] is detected).
Active hepatitis B and C based on the following results:
* positive for hepatitis B surface antigen (HepBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B)
* negative HepBsAg and positive for hepatitis B core antibody: negative HBV DNA by PCR result is necessary to enroll.
* positive Hepatitis C virus antibody (HepCAb): negative hepatitis C virus RNA by PCR result is necessary to enroll.
* Participant with symptoms and/or clinical signs and/or radiographic and/or sonographic signs that indicate an acute or uncontrolled chronic infection.
* Cancer chemotherapy for this newly diagnosed B cell ALL before the start of protocol-required therapy with the exception of IT chemotherapy or pre-phase chemotherapy. Radiation to a spot lesion such as chloroma or lytic lesion of bone or vertebrae for pain or vertebral stabilization is allowed.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/11/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
6/10/2031
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Actual
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Sample size
Target
287
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Canberra Hospital - Garran
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Recruitment hospital [2]
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Liverpool Hospital - Liverpool
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Recruitment hospital [3]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [4]
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Westmead Hospital - Westmead
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Recruitment hospital [5]
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Royal Brisbane and Womens Hospital - Herston
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Recruitment hospital [6]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [7]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [8]
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Monash Medical Centre - Clayton
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Recruitment hospital [9]
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Austin Health, Austin Hospital - Heidelberg
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Recruitment hospital [10]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [11]
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The Alfred Hospital - Melbourne
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Recruitment hospital [12]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2170 - Liverpool
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Recruitment postcode(s) [3]
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2065 - St Leonards
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Recruitment postcode(s) [4]
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2145 - Westmead
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Recruitment postcode(s) [5]
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4029 - Herston
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Recruitment postcode(s) [6]
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4102 - Woolloongabba
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Recruitment postcode(s) [7]
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5000 - Adelaide
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Recruitment postcode(s) [8]
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3168 - Clayton
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Recruitment postcode(s) [9]
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0
3084 - Heidelberg
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Recruitment postcode(s) [10]
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0
3000 - Melbourne
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Recruitment postcode(s) [11]
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3004 - Melbourne
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Recruitment postcode(s) [12]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Florida
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United States of America
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State/province [3]
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Ohio
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Country [4]
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United States of America
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State/province [4]
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South Carolina
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Country [5]
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United States of America
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State/province [5]
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Texas
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Country [6]
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Austria
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State/province [6]
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Graz
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Country [7]
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Austria
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State/province [7]
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Innsbruck
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Country [8]
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Austria
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State/province [8]
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Linz
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Country [9]
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Austria
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State/province [9]
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Wien
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Country [10]
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Belgium
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State/province [10]
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Anderlecht
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Country [11]
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Belgium
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State/province [11]
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Brugge
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Country [12]
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Belgium
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State/province [12]
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Bruxelles
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Country [13]
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Belgium
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State/province [13]
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Edegem
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Country [14]
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Belgium
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State/province [14]
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Gent
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Country [15]
0
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Belgium
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State/province [15]
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Hasselt
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Country [16]
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Belgium
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State/province [16]
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Liege
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Country [17]
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Belgium
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State/province [17]
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Roeselare
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Country [18]
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Belgium
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State/province [18]
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Yvoir
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Country [19]
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Brazil
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State/province [19]
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São Paulo
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Country [20]
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Bulgaria
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State/province [20]
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Plovdiv
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Country [21]
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Bulgaria
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State/province [21]
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Sofia
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Canada
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State/province [22]
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Alberta
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Canada
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State/province [23]
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Manitoba
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Country [24]
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Canada
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State/province [24]
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Nova Scotia
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Country [25]
0
0
Canada
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State/province [25]
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France
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France
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France
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France
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France
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Vandoeuvre les Nancy Cedex
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Patras
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Greece
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Debrecen
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Eger
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Hungary
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Italy
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Italy
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Italy
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Italy
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Roma
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Italy
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Busan
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Hwasun
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Seoul
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Mexico
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Distrito Federal
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Coimbra
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Goteborg
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Bern
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Taoyuan
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Ankara
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Istanbul
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Samsun
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Amgen
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Address
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Ethics approval
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Summary
Brief summary
The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy.
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Trial website
https://clinicaltrials.gov/study/NCT04994717
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Public notes
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Contacts
Principal investigator
Name
0
0
MD
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Address
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Amgen
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Contact person for public queries
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Amgen Call Center
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866-572-6436
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
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.
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Available to whom?
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.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04994717