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NCT02112916 · OUTCOME

Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT)

Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma · Source last updated 2026-07-29

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

Cumulative incidence of isolated CNS relapse adjusting for competing risks using the method of: Gray R, A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 1141:1154, 1988

Analysis population: T-ALL patients on AALL1231 who did not receive CRT or bortezomib: IR (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 \[NCT00408005\] Low Risk definition). T-ALL on AALL0434 \[NCT00408005\](who received CRT, no nelarabine) excluding Low Risk, CNS3, M3 Day 29, and EOC MRD \>0.1%

Groups in this outcome

AALL1231 T-ALL Patients

T-ALL patients on AALL1231 who did not receive prophylactic cranial radiation and did not receive bortezomib: Intermediate Risk T-ALL (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 Low Risk definition).

AALL0434 T-ALL Patients

T-ALL patients on AALL0434 \[NCT00408005\] who received prophylactic cranial radiation and did not receive nelarabine (exclude Low Risk, CNS3, M3 Day 29, and EOC MRD \>0.1%);

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
AALL1231 T-ALL Patients229
AALL0434 T-ALL Patients634

Reported measurements

Isolated CNS Relapse
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
AALL1231 T-ALL Patients3.6Not reported1.16.1Not reported
AALL0434 T-ALL Patients2.2Not reported1.03.4Not reported
Isolated Bone Marrow Relapse
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
AALL1231 T-ALL Patients1.4Not reported03.0Not reported
AALL0434 T-ALL Patients3.0Not reported1.64.4Not reported
Combined Bone Marrow Relapse
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
AALL1231 T-ALL Patients1.3Not reported02.9Not reported
AALL0434 T-ALL Patients1.8Not reported0.82.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.1
        upper Limit
        6.1
        value
        3.6
      2. group Id
        OG001
        lower Limit
        1.0
        upper Limit
        3.4
        value
        2.2
    title
    Isolated CNS Relapse
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        3.0
        value
        1.4
      2. group Id
        OG001
        lower Limit
        1.6
        upper Limit
        4.4
        value
        3.0
    title
    Isolated Bone Marrow Relapse
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        2.9
        value
        1.3
      2. group Id
        OG001
        lower Limit
        0.8
        upper Limit
        2.8
        value
        1.8
    title
    Combined Bone Marrow Relapse
denoms
  1. counts
    1. group Id
      OG000
      value
      229
    2. group Id
      OG001
      value
      634
    units
    Participants
description
Cumulative incidence of isolated CNS relapse adjusting for competing risks using the method of: Gray R, A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 1141:1154, 1988
dispersion Type
95% Confidence Interval
groups
  1. description
    T-ALL patients on AALL1231 who did not receive prophylactic cranial radiation and did not receive bortezomib: Intermediate Risk T-ALL (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 Low Risk definition).
    id
    OG000
    title
    AALL1231 T-ALL Patients
  2. description
    T-ALL patients on AALL0434 \[NCT00408005\] who received prophylactic cranial radiation and did not receive nelarabine (exclude Low Risk, CNS3, M3 Day 29, and EOC MRD \>0.1%);
    id
    OG001
    title
    AALL0434 T-ALL Patients
param Type
NUMBER
population Description
T-ALL patients on AALL1231 who did not receive CRT or bortezomib: IR (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 \[NCT00408005\] Low Risk definition). T-ALL on AALL0434 \[NCT00408005\](who received CRT, no nelarabine) excluding Low Risk, CNS3, M3 Day 29, and EOC MRD \>0.1%
reporting Status
POSTED
time Frame
3 years
title
Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice