Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02883049 · OUTCOME

Toxicity and Tolerability of Post-induction Age-adjusted ITT Compared to Age-adjusted IT MTX in Children With HR B-ALL

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
Up to 10 years

What was measured

(Completed effective March 19, 2018) Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, will be estimated for each randomized arm.

Analysis population: Patients risk assigned as HR B-ALL and randomized to the two post induction therapies (includes patients from AALL0932). Inevaluable and ineligible 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 A62.44Not reported59.265.7Not reported
Non-DS HR B-ALL Arm B63.39Not reported60.266.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        59.2
        upper Limit
        65.7
        value
        62.44
      2. group Id
        OG001
        lower Limit
        60.2
        upper Limit
        66.6
        value
        63.39
denoms
  1. counts
    1. group Id
      OG000
      value
      868
    2. group Id
      OG001
      value
      866
    units
    Participants
description
(Completed effective March 19, 2018) Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, will be estimated for each randomized arm.
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
Patients risk assigned as HR B-ALL and randomized to the two post induction therapies (includes patients from AALL0932). Inevaluable and ineligible patients were excluded from analysis.
reporting Status
POSTED
time Frame
Up to 10 years
title
Toxicity and Tolerability of Post-induction Age-adjusted ITT Compared to Age-adjusted IT MTX in Children With HR B-ALL
type
SECONDARY
unit Of Measure
Percentage of patients

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

Preserved source evidence · Not medical advice