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NCT02393859 · OUTCOME

Kaplan Meier Estimate: Event-Free Survival (EFS; Primary Analysis)

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
As of the primary analysis data cutoff date (17 July 2019), overall median follow-up time for EFS was 22.4 months.

What was measured

EFS is calculated from the time of randomization until the date of relapse or M2 marrow (representative bone marrow aspirate or biopsy with ≥ 5% and \< 25% blasts) after having achieved a complete remission (CR), failure to achieve a CR at the end of treatment, second malignancy, or death due to any cause, whichever occurs first. Participants who failed to achieve a CR following treatment with investigational product (IP) or who died before the disease assessment at the end of treatment were considered treatment failures and assigned an EFS duration of 1 day. Participants still alive and event-free were censored on their last disease assessment date. Participants were said to be in CR when they had the following: * M1 marrow * Peripheral blood without blasts * Absence of extramedullary leukemic involvement Months are calculated as days from randomization date to event/censor date, divided by 30.5.

Analysis population: Full Analysis Set: randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received (primary analysis population).

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 Chemotherapy54
Blinatumomab54

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy7.4Not reported4.512.7Not reported
BlinatumomabNANot reported12.0NANA=not estimable (median EFS and upper confidence interval \[CI\] were not reached at time of data cutoff)

Source statistical analyses

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

  1. estimate Comment
    A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.001
    p Value Comment
    Stratification factors were: 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).
    param Type
    Normal score
    param Value
    -11.54
    statistical Method
    Stratified log-rank test
  2. estimate Comment
    A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.001
    param Type
    Normal score
    param Value
    -11.16
    statistical Method
    Unstratified log-rank test
  3. ci Lower Limit
    0.19
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.66
    estimate Comment
    Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Stratified hazard ratio (HR)
    param Value
    0.36
  4. ci Lower Limit
    0.22
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.70
    estimate Comment
    Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Unstratified HR
    param Value
    0.39
  5. ci Lower Limit
    0.20
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.64
    estimate Comment
    Cox proportional hazard model including time from randomization to allogeneic hematopoietic stem cell transplant. Stratification factors: age and marrow/MRD status. (HR \<1.0=lower average event rate and longer EFS for blinatumomab relative to HC3.)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Stratified HR w/time-dependent covariate
    param Value
    0.36
Complete source fields
analyses
  1. estimate Comment
    A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.001
    p Value Comment
    Stratification factors were: 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).
    param Type
    Normal score
    param Value
    -11.54
    statistical Method
    Stratified log-rank test
  2. estimate Comment
    A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.001
    param Type
    Normal score
    param Value
    -11.16
    statistical Method
    Unstratified log-rank test
  3. ci Lower Limit
    0.19
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.66
    estimate Comment
    Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Stratified hazard ratio (HR)
    param Value
    0.36
  4. ci Lower Limit
    0.22
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.70
    estimate Comment
    Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Unstratified HR
    param Value
    0.39
  5. ci Lower Limit
    0.20
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.64
    estimate Comment
    Cox proportional hazard model including time from randomization to allogeneic hematopoietic stem cell transplant. Stratification factors: age and marrow/MRD status. (HR \<1.0=lower average event rate and longer EFS for blinatumomab relative to HC3.)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Stratified HR w/time-dependent covariate
    param Value
    0.36
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.5
        upper Limit
        12.7
        value
        7.4
      2. comment
        NA=not estimable (median EFS and upper confidence interval \[CI\] were not reached at time of data cutoff)
        group Id
        OG001
        lower Limit
        12.0
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    2. group Id
      OG001
      value
      54
    units
    Participants
description
EFS is calculated from the time of randomization until the date of relapse or M2 marrow (representative bone marrow aspirate or biopsy with ≥ 5% and \< 25% blasts) after having achieved a complete remission (CR), failure to achieve a CR at the end of treatment, second malignancy, or death due to any cause, whichever occurs first. Participants who failed to achieve a CR following treatment with investigational product (IP) or who died before the disease assessment at the end of treatment were considered treatment failures and assigned an EFS duration of 1 day. Participants still alive and event-free were censored on their last disease assessment date. Participants were said to be in CR when they had the following: * M1 marrow * Peripheral blood without blasts * Absence of extramedullary leukemic involvement Months are calculated as days from randomization date 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
Full Analysis Set: randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received (primary analysis population).
reporting Status
POSTED
time Frame
As of the primary analysis data cutoff date (17 July 2019), overall median follow-up time for EFS was 22.4 months.
title
Kaplan Meier Estimate: Event-Free Survival (EFS; Primary Analysis)
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice