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NCT02883049 · OUTCOME

DFS of Non-DS HR Post-induction Patients Receiving Intrathecal (IT) Methotrexate (MTX) Compared With Patients Receiving Intrathecal Triple Therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) Interim Maintenance High-dose Methotrexate Backbone

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 5 years

What was measured

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 2-sided log rank test, alpha = 5%. (Completed effective March 19, 2018)

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

Groups in this outcome

Non-DS HR B-ALL Arm A

Non-DS HR patients receive post induction age-adjusted intrathecal (IT) methotrexate (MTX)

Non-DS HR B-ALL Arm B

Non-DS HR patients receive post-Induction age-adjusted intrathecal triple therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) interim maintenance high-dose methotrexate (IMHDM) backbone

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 HR B-ALL Arm A868
Non-DS HR B-ALL Arm B866

Reported measurements

Source class 1
Values in Percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Non-DS HR B-ALL Arm A92.48Not reported90.794.3Not reported
Non-DS HR B-ALL Arm B92.33Not reported90.594.2Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.74
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.413
    estimate Comment
    Hazard ratio = hazard rate for Arm B/hazard rate for Arm A
    group Description
    To compare the DFS of the randomized patients on HR B-ALL Arm A vs Arm B. With a total of 1800 patients accrued over 5 years with minimum follow up of 2 years, randomized 1:1 to the 2 arms, we will be able to detect an improvement in 5-year DFS from 90% to 94 (HR=0.5873) between IT MTX and ITT based regimens (2-sided log rank test, alpha=5%), with 84.2% power.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.893
    param Type
    Hazard Ratio (HR)
    param Value
    1.022
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.74
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.413
    estimate Comment
    Hazard ratio = hazard rate for Arm B/hazard rate for Arm A
    group Description
    To compare the DFS of the randomized patients on HR B-ALL Arm A vs Arm B. With a total of 1800 patients accrued over 5 years with minimum follow up of 2 years, randomized 1:1 to the 2 arms, we will be able to detect an improvement in 5-year DFS from 90% to 94 (HR=0.5873) between IT MTX and ITT based regimens (2-sided log rank test, alpha=5%), with 84.2% power.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.893
    param Type
    Hazard Ratio (HR)
    param Value
    1.022
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        90.7
        upper Limit
        94.3
        value
        92.48
      2. group Id
        OG001
        lower Limit
        90.5
        upper Limit
        94.2
        value
        92.33
denoms
  1. counts
    1. group Id
      OG000
      value
      868
    2. group Id
      OG001
      value
      866
    units
    Participants
description
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 2-sided log rank test, alpha = 5%. (Completed effective March 19, 2018)
dispersion Type
95% Confidence Interval
groups
  1. description
    Non-DS HR patients receive post induction age-adjusted intrathecal (IT) methotrexate (MTX)
    id
    OG000
    title
    Non-DS HR B-ALL Arm A
  2. description
    Non-DS HR patients receive post-Induction age-adjusted intrathecal triple therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) interim maintenance high-dose methotrexate (IMHDM) backbone
    id
    OG001
    title
    Non-DS HR B-ALL Arm B
param Type
NUMBER
population Description
Non-DS HR B-ALL patients with post induction therapies (includes patients from AALL0932). Inevaluable patients were excluded from analysis.
reporting Status
POSTED
time Frame
At 5 years
title
DFS of Non-DS HR Post-induction Patients Receiving Intrathecal (IT) Methotrexate (MTX) Compared With Patients Receiving Intrathecal Triple Therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) Interim Maintenance High-dose Methotrexate Backbone
type
PRIMARY
unit Of Measure
Percentage of patients

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Preserved source evidence · Not medical advice