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NCT02393859 · OUTCOME

Percentage of Participants With an MRD Response Within 29 Days of Treatment Initiation

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.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to End of Treatment (Cycle 1, Day 29)

What was measured

At the end of the first treatment cycle (Day 29) a bone marrow aspiration/biopsy was performed and evaluated by the central MRD laboratory. MRD response was defined as MRD level \< 10\^-4, by polymerase chain reaction (PCR) or flow cytometry, at the end of treatment (Cycle 1 Day 29) with study drug. Participants who were part of the MRD Evaluable Set and were missing the end of treatment (Cycle 1 Day 29) assessment for a respective MRD assessment method were considered not to have achieved a response.

Analysis population: MRD Evaluable Set: participants for whom an evaluable baseline MRD marker can be found with either of the MRD assessment methods of PCR or flow cytometry.

Groups in this outcome

HC3 Chemotherapy

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 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 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).

Blinatumomab

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
HC3 Chemotherapy56
Blinatumomab54

Reported measurements

MRD Response by PCR

Analysis denominator · Participants

GroupSource count
HC3 Chemotherapy49
Blinatumomab49
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy53.1Not reported38.367.5Not reported
Blinatumomab93.9Not reported83.198.7Not reported
MRD Response by Flow Cytometry

Analysis denominator · Participants

GroupSource count
HC3 Chemotherapy55
Blinatumomab54
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy60.0Not reported45.973.0Not reported
Blinatumomab92.6Not reported82.197.9Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    MRD response by PCR
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.001
    p Value Comment
    Cochran-Mantel-Haenszel test adjusting for the stratification factors: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).
    statistical Method
    Cochran-Mantel-Haenszel
  2. group Description
    MRD response by flow cytometry
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.001
    p Value Comment
    Cochran-Mantel-Haenszel test adjusting for the stratification factors: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10-3 vs M1 with MRD level ≥ 10-3 vs M2).
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. group Description
    MRD response by PCR
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.001
    p Value Comment
    Cochran-Mantel-Haenszel test adjusting for the stratification factors: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).
    statistical Method
    Cochran-Mantel-Haenszel
  2. group Description
    MRD response by flow cytometry
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.001
    p Value Comment
    Cochran-Mantel-Haenszel test adjusting for the stratification factors: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10-3 vs M1 with MRD level ≥ 10-3 vs M2).
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        38.3
        upper Limit
        67.5
        value
        53.1
      2. group Id
        OG001
        lower Limit
        83.1
        upper Limit
        98.7
        value
        93.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        49
      units
      Participants
    title
    MRD Response by PCR
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        45.9
        upper Limit
        73.0
        value
        60.0
      2. group Id
        OG001
        lower Limit
        82.1
        upper Limit
        97.9
        value
        92.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        55
      2. group Id
        OG001
        value
        54
      units
      Participants
    title
    MRD Response by Flow Cytometry
denoms
  1. counts
    1. group Id
      OG000
      value
      56
    2. group Id
      OG001
      value
      54
    units
    Participants
description
At the end of the first treatment cycle (Day 29) a bone marrow aspiration/biopsy was performed and evaluated by the central MRD laboratory. MRD response was defined as MRD level \< 10\^-4, by polymerase chain reaction (PCR) or flow cytometry, at the end of treatment (Cycle 1 Day 29) with study drug. Participants who were part of the MRD Evaluable Set and were missing the end of treatment (Cycle 1 Day 29) assessment for a respective MRD assessment method were considered not to have achieved a response.
dispersion Type
95% Confidence Interval
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 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 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
    OG000
    title
    HC3 Chemotherapy
  2. description
    One 4-week cycle of blinatumomab 15 μg/m\^2/day as a continuous intravenous infusion (CIVI).
    id
    OG001
    title
    Blinatumomab
param Type
NUMBER
population Description
MRD Evaluable Set: participants for whom an evaluable baseline MRD marker can be found with either of the MRD assessment methods of PCR or flow cytometry.
reporting Status
POSTED
time Frame
Up to End of Treatment (Cycle 1, Day 29)
title
Percentage of Participants With an MRD Response Within 29 Days of Treatment Initiation
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice