Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02003222 · OUTCOME

Relapse-free Survival (RFS) Among Patients Who Were MRD Negative After Induction and Intensification 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

RFS was defined as time from randomization to relapse or to death without documentation of relapse. Patients without events were censored at the date of last disease assessment. Relapse/Persistent Disease Persistent disease/Relapse following complete remission (CR)/complete remission incomplete (CRi) is defined as: * Reappearance or persistence of blasts in the blood * Presence of \> 5% blasts, not attributable to another cause (e.g., bone marrow regeneration). * In the case of isolated CNS relapse such as a positive cytospin examination of CSF, please consult with Study Chair. Perform bone marrow biopsy (if not already done) to confirm presence or lack of medullary relapse.

Analysis population: All MRD-negative patients randomized to either blinatumomab + chemotherapy or chemotherapy alone were included in this analysis.

Groups in this outcome

MRD Negative - Blinatumomab + Chemotherapy

MRD negative patients received induction treatment and intensification treatment and then were randomized to receive blinatumomab plus chemotherapy.

MRD Negative - Chemotherapy

MRD negative patients received induction treatment and intensification treatment and then were randomized to receive 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 Negative - Blinatumomab + Chemotherapy112
MRD Negative - Chemotherapy112

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
MRD Negative - Blinatumomab + ChemotherapyNANot reported37.1NAMedian RFS not reached The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
MRD Negative - Chemotherapy35.2Not reported30.369.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.31
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.89
    estimate Comment
    hazard ratio: Blinatumomab + Chemotherapy vs. Chemotherapy alone
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.015
    param Type
    Hazard Ratio (HR)
    param Value
    0.53
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.31
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.89
    estimate Comment
    hazard ratio: Blinatumomab + Chemotherapy vs. Chemotherapy alone
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.015
    param Type
    Hazard Ratio (HR)
    param Value
    0.53
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Median RFS not reached The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
        group Id
        OG000
        lower Limit
        37.1
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        30.3
        upper Limit
        69.0
        value
        35.2
denoms
  1. counts
    1. group Id
      OG000
      value
      112
    2. group Id
      OG001
      value
      112
    units
    Participants
description
RFS was defined as time from randomization to relapse or to death without documentation of relapse. Patients without events were censored at the date of last disease assessment. Relapse/Persistent Disease Persistent disease/Relapse following complete remission (CR)/complete remission incomplete (CRi) is defined as: * Reappearance or persistence of blasts in the blood * Presence of \> 5% blasts, not attributable to another cause (e.g., bone marrow regeneration). * In the case of isolated CNS relapse such as a positive cytospin examination of CSF, please consult with Study Chair. Perform bone marrow biopsy (if not already done) to confirm presence or lack of medullary relapse.
dispersion Type
95% Confidence Interval
groups
  1. description
    MRD negative patients received induction treatment and intensification treatment and then were randomized to receive blinatumomab plus chemotherapy.
    id
    OG000
    title
    MRD Negative - Blinatumomab + Chemotherapy
  2. description
    MRD negative patients received induction treatment and intensification treatment and then were randomized to receive chemotherapy.
    id
    OG001
    title
    MRD Negative - Chemotherapy
param Type
MEDIAN
population Description
All MRD-negative patients randomized to either blinatumomab + chemotherapy or chemotherapy alone were included in this 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
Relapse-free Survival (RFS) Among Patients Who Were MRD Negative After Induction and Intensification Chemotherapy
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice