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NCT02883049 · OUTCOME

DFS of Non-DS VHR Post-Induction Patients Who Receive a Modified MBFM-IMHDM Regimen That Contains a Second IM (Control Arm) Compared to Patients Receive the Cyclophosphamide + Etoposide Containing Regimen (Experimental Arm 1)

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations · Source last updated 2026-06-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of patients
Interval / dispersion
95% Confidence Interval
Time frame
At 4 years

What was measured

(Completed effective February 15, 2017) DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. Compared using a 1-sided log rank test, alpha of 2.5%.

Analysis population: Non-DS VHR B-ALL patients with post induction therapies (includes patients from AALL0932). Inevaluable patients were excluded from analysis.

Groups in this outcome

Non-DS VHR B-ALL Control Arm

Non-DS VHR patients receive a modified MBFM-IMHDM regimen that contains a second IM (Control Arm)

Non-DS VHR B-ALL Exp Arm1

Non-DS VHR patients receive cyclophosphamide + etoposide containing regimen (Experimental Arm 1)

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

Analysis denominator · Participants

GroupSource count
Non-DS VHR B-ALL Control Arm335
Non-DS VHR B-ALL Exp Arm1488

Reported measurements

Source class 1
Values in Percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Non-DS VHR B-ALL Control Arm77.11Not reported72.481.8Not reported
Non-DS VHR B-ALL Exp Arm176.75Not reported72.880.7Not reported

Source statistical analyses

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

  1. ci Num Sides
    ONE_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    1.335
    estimate Comment
    Hazard ratio = hazard rate for Experimental Arm 1 /hazard rate for Control Arm
    group Description
    To compare the DFS of the randomized patients on Control Arm vs. Experimental Arm 1. This study design will have 86.8% power (1-sided log rank test, adjusted alpha=0.025 for multiple comparisons) to detect an improvement in 4-year DFS from 70% to 79% (HR=0.661) between the control arm and the experimental arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.556
    param Type
    Hazard Ratio (HR)
    param Value
    1.019
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Num Sides
    ONE_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    1.335
    estimate Comment
    Hazard ratio = hazard rate for Experimental Arm 1 /hazard rate for Control Arm
    group Description
    To compare the DFS of the randomized patients on Control Arm vs. Experimental Arm 1. This study design will have 86.8% power (1-sided log rank test, adjusted alpha=0.025 for multiple comparisons) to detect an improvement in 4-year DFS from 70% to 79% (HR=0.661) between the control arm and the experimental arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.556
    param Type
    Hazard Ratio (HR)
    param Value
    1.019
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        72.4
        upper Limit
        81.8
        value
        77.11
      2. group Id
        OG001
        lower Limit
        72.8
        upper Limit
        80.7
        value
        76.75
denoms
  1. counts
    1. group Id
      OG000
      value
      335
    2. group Id
      OG001
      value
      488
    units
    Participants
description
(Completed effective February 15, 2017) DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. Compared using a 1-sided log rank test, alpha of 2.5%.
dispersion Type
95% Confidence Interval
groups
  1. description
    Non-DS VHR patients receive a modified MBFM-IMHDM regimen that contains a second IM (Control Arm)
    id
    OG000
    title
    Non-DS VHR B-ALL Control Arm
  2. description
    Non-DS VHR patients receive cyclophosphamide + etoposide containing regimen (Experimental Arm 1)
    id
    OG001
    title
    Non-DS VHR B-ALL Exp Arm1
param Type
NUMBER
population Description
Non-DS VHR B-ALL patients with post induction therapies (includes patients from AALL0932). Inevaluable patients were excluded from analysis.
reporting Status
POSTED
time Frame
At 4 years
title
DFS of Non-DS VHR Post-Induction Patients Who Receive a Modified MBFM-IMHDM Regimen That Contains a Second IM (Control Arm) Compared to Patients Receive the Cyclophosphamide + Etoposide Containing Regimen (Experimental Arm 1)
type
PRIMARY
unit Of Measure
Percentage of patients

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

Preserved source evidence · Not medical advice