NCT02883049 · OUTCOME

Overall Survival (OS) Rate for VHR B-ALL Patients, Overall and by Randomized Arm.

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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

OS of VHR-B-ALL 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). OS time is defined as time from enrollment to death or date of last contact for patients who are alive. 4-year OS will be estimated for the two randomized arms using the Kaplan-Meier method.

Analysis population: VHR B-ALL patients with post induction therapies (includes patients from AALL0932). Experimental Arm 2 was closed early in the study due to excessive toxicities. The objectives and study design for VHR patients was modified to be limited to the two arms (Control vs Experimental Arm 1). Inevaluable and ineligible patients were also excluded from analysis.

Groups in this outcome

Non-DS VHR B-ALL Overall

Total Non-DS VHR B-ALL patients

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 Experimental Arm 1

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

Group	Source count
Non-DS VHR B-ALL Overall	915
Non-DS VHR B-ALL Control Arm	335
Non-DS VHR B-ALL Experimental Arm 1	488

Reported measurements

Source class 1

Values in Percentage of patients · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Non-DS VHR B-ALL Overall	87.87	Not reported	85.6	90.1	Not reported
Non-DS VHR B-ALL Control Arm	87.31	Not reported	83.6	91.1	Not reported
Non-DS VHR B-ALL Experimental Arm 1	88.50	Not reported	85.5	91.5	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
85.6
upper Limit
90.1
value
87.87
group Id
OG001
lower Limit
83.6
upper Limit
91.1
value
87.31
group Id
OG002
lower Limit
85.5
upper Limit
91.5
value
88.50

denoms

counts
group Id
OG000
value
915
group Id
OG001
value
335
group Id
OG002
value
488
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Total Non-DS VHR B-ALL patients
id
OG000
title
Non-DS VHR B-ALL Overall
description
Non-DS VHR patients receive a modified MBFM-IMHDM regimen that contains a second IM (Control Arm)
id
OG001
title
Non-DS VHR B-ALL Control Arm
description
Non-DS VHR patients receive cyclophosphamide + etoposide containing regimen (Experimental Arm 1)
id
OG002
title
Non-DS VHR B-ALL Experimental Arm 1

param Type

NUMBER

population Description

VHR B-ALL patients with post induction therapies (includes patients from AALL0932). Experimental Arm 2 was closed early in the study due to excessive toxicities. The objectives and study design for VHR patients was modified to be limited to the two arms (Control vs Experimental Arm 1). Inevaluable and ineligible patients were also excluded from analysis.

reporting Status

POSTED

time Frame

At 4 years

title

Overall Survival (OS) Rate for VHR B-ALL Patients, Overall and by Randomized Arm.

type

SECONDARY

unit Of Measure

Percentage of patients

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

Preserved source evidence · Not medical advice