NCT02112916 · OUTCOME

EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3

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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 participants
Interval / dispersion: 95% Confidence Interval
Time frame: 3 years

What was measured

EFS will be calculated as time from the end of the three high-risk blocks of therapy to first event (relapse, second malignancy, remission death) or date of last contact.

Analysis population: VHR T-ALL patients who had EOC MRD \>= 0.1%, completed the three high-risk blocks of therapy, and had MRD assessment done after the three high-risk blocks. MRD was not performed in T-LLy patients at end of the VHR blocks. MRD is not used in T-LLy to measure disease response. This outcome measure was pre-specified to only be assessed in the T-ALL patients.

Groups in this outcome

VHR T-ALL MRD Undetectable

VHR T-ALL patients (with end of consolidation \[EOC\] MRD \>= 0.1%) who become MRD negative (MRD undetectable) after the three high-risk BFM blocks of therapy

VHR T-ALL MRD Detectable

VHR T-ALL patients (with end of consolidation \[EOC\] MRD \>= 0.1%) who continue to have detectable MRD after the three high-risk BFM blocks of therapy.

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
VHR T-ALL MRD Undetectable	8
VHR T-ALL MRD Detectable	10

Reported measurements

Source class 1

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
VHR T-ALL MRD Undetectable	25.0	Not reported	0	67.5	Not reported
VHR T-ALL MRD Detectable	88.9	Not reported	59.0	100	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0
upper Limit
67.5
value
25.0
group Id
OG001
lower Limit
59.0
upper Limit
100
value
88.9

denoms

counts
group Id
OG000
value
8
group Id
OG001
value
10
units
Participants

description

EFS will be calculated as time from the end of the three high-risk blocks of therapy to first event (relapse, second malignancy, remission death) or date of last contact.

dispersion Type

95% Confidence Interval

groups

description
VHR T-ALL patients (with end of consolidation \[EOC\] MRD \>= 0.1%) who become MRD negative (MRD undetectable) after the three high-risk BFM blocks of therapy
id
OG000
title
VHR T-ALL MRD Undetectable
description
VHR T-ALL patients (with end of consolidation \[EOC\] MRD \>= 0.1%) who continue to have detectable MRD after the three high-risk BFM blocks of therapy.
id
OG001
title
VHR T-ALL MRD Detectable

param Type

NUMBER

population Description

VHR T-ALL patients who had EOC MRD \>= 0.1%, completed the three high-risk blocks of therapy, and had MRD assessment done after the three high-risk blocks. MRD was not performed in T-LLy patients at end of the VHR blocks. MRD is not used in T-LLy to measure disease response. This outcome measure was pre-specified to only be assessed in the T-ALL patients.

reporting Status

POSTED

time Frame

3 years

title

EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3

type

SECONDARY

unit Of Measure

Percentage of participants

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

Preserved source evidence · Not medical advice