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NCT02003222 · OUTCOME

OS Among of Those Who Are MRD+ at Randomization and Then Convert to MRD- After 2 Cycles of Blinatumomab to Those Patients Who Are MRD- at Randomization and Remain MRD- After 2 Cycles of Blinatumomab or Consolidation Chemotherapy

Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia · Source last updated 2026-08-04

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
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

What was measured

OS was defined as time from end of 2 cycles of blinatumomab to death of any cause

Analysis population: Patients with MRD data at the end of 2 cycles of blinatumomab were included in the analysis.

Groups in this outcome

MRD+ Then Convert to MRD-

Patients who are MRD positive (MRD+) at randomization/registration and then convert to MRD negative (MRD-) after 2 cycles of blinatumomab or consolidation chemotherapy. .

MRD- Then Remain MRD-

Patients who are MRD negative (MRD-) at randomization/registration and then remain MRD negative (MRD-) after 2 cycles of blinatumomab or consolidation chemotherapy. .

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

Analysis denominator · Participants

GroupSource count
MRD+ Then Convert to MRD-28
MRD- Then Remain MRD-89

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
MRD+ Then Convert to MRD-NANot reportedNANAMedian OS not reached The 95% confidence intervals were not calculable because an insufficient number of participants reached the event at the final time point for assessment.
MRD- Then Remain MRD-NANot reportedNANAMedian OS not reached The 95% confidence intervals were not calculable because an insufficient number of participants reached the event at the final time point for assessment.

Source statistical analyses

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

  1. ci Lower Limit
    0.28
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.63
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    1.00
    param Type
    Hazard Ratio (HR)
    param Value
    1.00
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.28
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.63
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    1.00
    param Type
    Hazard Ratio (HR)
    param Value
    1.00
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Median OS not reached The 95% confidence intervals were not calculable because an insufficient number of participants reached the event at the final time point for assessment.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median OS not reached The 95% confidence intervals were not calculable because an insufficient number of participants reached the event at the final time point for assessment.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    2. group Id
      OG001
      value
      89
    units
    Participants
description
OS was defined as time from end of 2 cycles of blinatumomab to death of any cause
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients who are MRD positive (MRD+) at randomization/registration and then convert to MRD negative (MRD-) after 2 cycles of blinatumomab or consolidation chemotherapy. .
    id
    OG000
    title
    MRD+ Then Convert to MRD-
  2. description
    Patients who are MRD negative (MRD-) at randomization/registration and then remain MRD negative (MRD-) after 2 cycles of blinatumomab or consolidation chemotherapy. .
    id
    OG001
    title
    MRD- Then Remain MRD-
param Type
MEDIAN
population Description
Patients with MRD data at the end of 2 cycles of blinatumomab were included in the analysis.
reporting Status
POSTED
time Frame
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
title
OS Among of Those Who Are MRD+ at Randomization and Then Convert to MRD- After 2 Cycles of Blinatumomab to Those Patients Who Are MRD- at Randomization and Remain MRD- After 2 Cycles of Blinatumomab or Consolidation Chemotherapy
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice