Participant flow

Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) · Source last updated 2026-06-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m\^2/day intravenous \[IV\] on Days 1-6), vincrisitne (1.5 mg/m\^2/day IV on Days 1 and 6), daunorubicin (30 mg/m\^2 IV over 24 hours on Day 5), methotrexate (1 g/m\^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m\^2 IV for 1 hour on Days 2-4), and pegylated \[PEG\]-asparaginase (1000 U/m\^2 IV for 2 hours or intramuscularly \[IM\] on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m\^2 IV or IM every 48 hours for a total of 6 doses).

   id

   FG000

   title

   HC3 Chemotherapy

2. description

   One 4-week cycle of blinatumomab 15 μg/m\^2/day as a continuous intravenous infusion (CIVI).

   id

   FG001

   title

   Blinatumomab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      type

      Decision by Sponsor

   2. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         6

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         27

      2. group Id

         FG001

         num Subjects

         10

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         57

      2. group Id

         FG001

         num Subjects

         54

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         52

      2. group Id

         FG001

         num Subjects

         54

      type

      Participants Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         54

      2. group Id

         FG001

         num Subjects

         54

      comment

      Included all randomized participants analyzed according to their randomized treatment assignment, regardless of treatment received (the full analysis set; FAS) at the primary completion date (17 July 2019)

      type

      Participants in the Primary Analysis Population

   4. achievements

      1. group Id

         FG000

         num Subjects

         57

      2. group Id

         FG001

         num Subjects

         54

      comment

      Included all randomized participants analyzed according to their randomized treatment assignment, regardless of treatment received (FAS) at study completion (21 November 2022)

      type

      Participants in the Final Analysis Population

   5. achievements

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         33

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         41

      2. group Id

         FG001

         num Subjects

         21

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

After a 3-week screening period, participants were enrolled and randomized 1:1 into 1 of 2 treatment groups: High Risk Consolidation 3 (HC3) chemotherapy or blinatumomab. Randomization was stratified by age and bone marrow/minimal residual disease (MRD) status.

recruitment Details

This study was conducted at 48 centers across 13 countries (Europe, Australia, Israel). The first participant was enrolled on 10 November 2015. The last participant enrolled on 30 August 2019. The primary completion date was 17 July 2019 and the study completion date was 21 November 2022.

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Preserved source evidence · Not medical advice