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NCT02883049 · OUTCOME

Toxicity and Tolerability of Experimental Arm 1 and Control Arm in Patients With VHR 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

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. (Closed effective February 15, 2017)

Analysis population: (includes patients from AALL0932). Inevaluable and ineligible 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 Arm1448

Reported measurements

Source class 1
Values in Percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Non-DS VHR B-ALL Control Arm66.27Not reported61.271.3Not reported
Non-DS VHR B-ALL Exp Arm173.16Not reported69.277.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        61.2
        upper Limit
        71.3
        value
        66.27
      2. group Id
        OG001
        lower Limit
        69.2
        upper Limit
        77.1
        value
        73.16
denoms
  1. counts
    1. group Id
      OG000
      value
      335
    2. group Id
      OG001
      value
      448
    units
    Participants
description
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. (Closed effective February 15, 2017)
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
(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 Experimental Arm 1 and Control Arm in Patients With VHR B-ALL
type
SECONDARY
unit Of Measure
Percentage of patients

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

Preserved source evidence · Not medical advice