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NCT02393859 · OUTCOME

Cumulative Incidence of Relapse (CIR)

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
At final analysis, the overall maximum follow-up time was 82.0 months.

What was measured

CIR estimate, presented as median months to relapse, calculated from date of achievement of first CR, using the cumulative incidence method (Fine JP, Gray RJ:1999). Deaths prior to relapse not considered related to an otherwise undocumented relapse were treated as a competing risk. Participants still alive without a date of relapse were censored at the time of last follow-up. Relapse=presence of ≥1 of the following: * isolated bone marrow relapse (M3 marrow \[representative bone marrow aspirate or biopsy with ≥25% blasts\] in the absence of extramedullary involvement) * combined bone marrow relapse (M2 \[representative bone marrow aspirate or biopsy with ≥5% and \<25% blasts\] or M3 marrow and ≥1 extramedullary manifestation of acute lymphoblastic leukemia) * central nervous system extramedullary relapse * testicular extramedullary relapse * extramedullary relapse at other sites Months were calculated as days from randomization to event/censor date, divided by 30.5.

Analysis population: FAS: randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received.

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 Chemotherapy57
Blinatumomab54

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy7.9Not reported5.818.6Not reported
BlinatumomabNANot reportedNANANA=not estimable (median CIR and confidence intervals were not reached at final analysis)

Source statistical analyses

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

  1. ci Lower Limit
    0.16
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.52
    estimate Comment
    The subdistribution HR estimates are obtained from the subdistribution Cox model. (HR \< 1.0 indicates a lower average event rate and a longer relapse-free time for blinatumomab relative to HC3.)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.29
  2. ci Lower Limit
    0.15
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.48
    estimate Comment
    The subdistribution HR estimates are obtained from the subdistribution Cox model. (HR \< 1.0 indicates a lower average event rate and a longer relapse-free time for blinatumomab relative to HC3.) Stratification factors are age and marrow/MRD status.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Stratified hazard ratio (HR)
    param Value
    0.27
Complete source fields
analyses
  1. ci Lower Limit
    0.16
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.52
    estimate Comment
    The subdistribution HR estimates are obtained from the subdistribution Cox model. (HR \< 1.0 indicates a lower average event rate and a longer relapse-free time for blinatumomab relative to HC3.)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.29
  2. ci Lower Limit
    0.15
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.48
    estimate Comment
    The subdistribution HR estimates are obtained from the subdistribution Cox model. (HR \< 1.0 indicates a lower average event rate and a longer relapse-free time for blinatumomab relative to HC3.) Stratification factors are age and marrow/MRD status.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Stratified hazard ratio (HR)
    param Value
    0.27
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.8
        upper Limit
        18.6
        value
        7.9
      2. comment
        NA=not estimable (median CIR and confidence intervals were not reached at final analysis)
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      57
    2. group Id
      OG001
      value
      54
    units
    Participants
description
CIR estimate, presented as median months to relapse, calculated from date of achievement of first CR, using the cumulative incidence method (Fine JP, Gray RJ:1999). Deaths prior to relapse not considered related to an otherwise undocumented relapse were treated as a competing risk. Participants still alive without a date of relapse were censored at the time of last follow-up. Relapse=presence of ≥1 of the following: * isolated bone marrow relapse (M3 marrow \[representative bone marrow aspirate or biopsy with ≥25% blasts\] in the absence of extramedullary involvement) * combined bone marrow relapse (M2 \[representative bone marrow aspirate or biopsy with ≥5% and \<25% blasts\] or M3 marrow and ≥1 extramedullary manifestation of acute lymphoblastic leukemia) * central nervous system extramedullary relapse * testicular extramedullary relapse * extramedullary relapse at other sites Months were calculated as days from randomization to event/censor date, divided by 30.5.
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
MEDIAN
population Description
FAS: randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received.
reporting Status
POSTED
time Frame
At final analysis, the overall maximum follow-up time was 82.0 months.
title
Cumulative Incidence of Relapse (CIR)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice