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NCT00408005 · OUTCOME

Cumulative Incidence of CNS Relapse for T-ALL by Risk Group

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma · Source last updated 2026-06-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percent probability
Interval / dispersion
95% Confidence Interval
Time frame
4 years from randomization at the end of induction

What was measured

Cumulative incidence of CNS relapse adjusting for DFS events, was calculated using the method Gray et. al. High risk patients receive cranial radiation and low risk patients receive no cranial radiation.

Analysis population: Includes only low risk, intermediate risk and high risk T-cell Acute Lymphoblastic Leukemia (T-ALL) subjects. There were no low risk participants on Arm II and Arm IV. Patients with CNS3, and Induction Failures are excluded from this analysis.

Groups in this outcome

ARM I (Combination Chemotherapy)

No Nelarabine, Capizzi Methotrexate

ARM II (Combination Chemotherapy)

Nelarabine, Capizzi Methotrexate

ARM III (Combination Chemotherapy)

No Nelarabine, High-Dose Methotrexate

ARM IV (Combination Chemotherapy)

Nelarabine, High-Dose Methotrexate

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

Analysis denominator · Participants

GroupSource count
ARM I (Combination Chemotherapy)372
ARM II (Combination Chemotherapy)147
ARM III (Combination Chemotherapy)451
ARM IV (Combination Chemotherapy)176

Reported measurements

Low Risk

Analysis denominator · Participants

GroupSource count
ARM I (Combination Chemotherapy)54
ARM II (Combination Chemotherapy)0
ARM III (Combination Chemotherapy)55
ARM IV (Combination Chemotherapy)0
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ARM I (Combination Chemotherapy)1.85Not reported05.5Not reported
ARM III (Combination Chemotherapy)1.92Not reported05.7Not reported
Intermediate Risk

Analysis denominator · Participants

GroupSource count
ARM I (Combination Chemotherapy)262
ARM II (Combination Chemotherapy)95
ARM III (Combination Chemotherapy)333
ARM IV (Combination Chemotherapy)118
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ARM I (Combination Chemotherapy)1.16Not reported02.5Not reported
ARM II (Combination Chemotherapy)1.08Not reported03.2Not reported
ARM III (Combination Chemotherapy)9.1Not reported6.012.2Not reported
ARM IV (Combination Chemotherapy)0.85Not reported02.5Not reported
High Risk

Analysis denominator · Participants

GroupSource count
ARM I (Combination Chemotherapy)56
ARM II (Combination Chemotherapy)52
ARM III (Combination Chemotherapy)63
ARM IV (Combination Chemotherapy)58
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ARM I (Combination Chemotherapy)3.64Not reported08.6Not reported
ARM II (Combination Chemotherapy)0Not reported00Not reported
ARM III (Combination Chemotherapy)6.52Not reported0.312.8Not reported
ARM IV (Combination Chemotherapy)3.45Not reported08.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        5.5
        value
        1.85
      2. group Id
        OG002
        lower Limit
        0
        upper Limit
        5.7
        value
        1.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        55
      4. group Id
        OG003
        value
        0
      units
      Participants
    title
    Low Risk
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        2.5
        value
        1.16
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        3.2
        value
        1.08
      3. group Id
        OG002
        lower Limit
        6.0
        upper Limit
        12.2
        value
        9.1
      4. group Id
        OG003
        lower Limit
        0
        upper Limit
        2.5
        value
        0.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        262
      2. group Id
        OG001
        value
        95
      3. group Id
        OG002
        value
        333
      4. group Id
        OG003
        value
        118
      units
      Participants
    title
    Intermediate Risk
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        8.6
        value
        3.64
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        0
      3. group Id
        OG002
        lower Limit
        0.3
        upper Limit
        12.8
        value
        6.52
      4. group Id
        OG003
        lower Limit
        0
        upper Limit
        8.2
        value
        3.45
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        52
      3. group Id
        OG002
        value
        63
      4. group Id
        OG003
        value
        58
      units
      Participants
    title
    High Risk
denoms
  1. counts
    1. group Id
      OG000
      value
      372
    2. group Id
      OG001
      value
      147
    3. group Id
      OG002
      value
      451
    4. group Id
      OG003
      value
      176
    units
    Participants
description
Cumulative incidence of CNS relapse adjusting for DFS events, was calculated using the method Gray et. al. High risk patients receive cranial radiation and low risk patients receive no cranial radiation.
dispersion Type
95% Confidence Interval
groups
  1. description
    No Nelarabine, Capizzi Methotrexate
    id
    OG000
    title
    ARM I (Combination Chemotherapy)
  2. description
    Nelarabine, Capizzi Methotrexate
    id
    OG001
    title
    ARM II (Combination Chemotherapy)
  3. description
    No Nelarabine, High-Dose Methotrexate
    id
    OG002
    title
    ARM III (Combination Chemotherapy)
  4. description
    Nelarabine, High-Dose Methotrexate
    id
    OG003
    title
    ARM IV (Combination Chemotherapy)
param Type
NUMBER
population Description
Includes only low risk, intermediate risk and high risk T-cell Acute Lymphoblastic Leukemia (T-ALL) subjects. There were no low risk participants on Arm II and Arm IV. Patients with CNS3, and Induction Failures are excluded from this analysis.
reporting Status
POSTED
time Frame
4 years from randomization at the end of induction
title
Cumulative Incidence of CNS Relapse for T-ALL by Risk Group
type
SECONDARY
unit Of Measure
percent probability

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

Preserved source evidence · Not medical advice