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NCT00381680 · OUTCOME

Event Free Survival (EFS)

Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia · Source last updated 2024-03-26

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

Percentage of patients who were event free at 3 years among those with isolated BM or combined BM relapse \>= 36 months.

Analysis population: The percentage of patients (pts) who were event free at 3 years among those with isolated BM or combined BM relapse \>= 36 months. Pts with MRD \<0.01% at the end of Block 1 (MRD \< 0.01% BL1); MRD \>= 0.01% at the end of Block 1 (MRD\>= 0.01% BL1); MRD \< 0.01% at the end of Block 3 (MRD \< 0.01% BL3);MRD \>=0.01% at the end of Block 3.

Groups in this outcome

Regimen A

Standard VCR dosing (1.5 mg/m\^2, max 2mg)

Regimen B

Intensive VCR dosing (2 mg/m\^2, max 2.5 mg)

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

Analysis denominator · Participants

GroupSource count
Regimen A127
Regimen B54

Reported measurements

MRD < 0.01% BL1

Analysis denominator · Participants

GroupSource count
Regimen A62
Regimen B22
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regimen A88.5Not reported80.496.6Not reported
Regimen B77.3Not reported59.894.8Not reported
MRD >= 0.01% BL1

Analysis denominator · Participants

GroupSource count
Regimen A60
Regimen B31
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regimen A60.0Not reported47.672.4Not reported
Regimen B46.2Not reported27.864.7Not reported
MRD < 0.01% BL3

Analysis denominator · Participants

GroupSource count
Regimen A57
Regimen B24
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regimen A83.8Not reported74.093.5Not reported
Regimen B83.3Not reported68.498.2Not reported
MRD >= 0.01% BL3

Analysis denominator · Participants

GroupSource count
Regimen A13
Regimen B3
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regimen A61.5Not reported35.188.0Not reported
Regimen B33.3Not reported0.086.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        80.4
        upper Limit
        96.6
        value
        88.5
      2. group Id
        OG001
        lower Limit
        59.8
        upper Limit
        94.8
        value
        77.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        62
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    MRD < 0.01% BL1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        47.6
        upper Limit
        72.4
        value
        60.0
      2. group Id
        OG001
        lower Limit
        27.8
        upper Limit
        64.7
        value
        46.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        60
      2. group Id
        OG001
        value
        31
      units
      Participants
    title
    MRD >= 0.01% BL1
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        74.0
        upper Limit
        93.5
        value
        83.8
      2. group Id
        OG001
        lower Limit
        68.4
        upper Limit
        98.2
        value
        83.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    MRD < 0.01% BL3
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        35.1
        upper Limit
        88.0
        value
        61.5
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        86.7
        value
        33.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    MRD >= 0.01% BL3
denoms
  1. counts
    1. group Id
      OG000
      value
      127
    2. group Id
      OG001
      value
      54
    units
    Participants
description
Percentage of patients who were event free at 3 years among those with isolated BM or combined BM relapse \>= 36 months.
dispersion Type
95% Confidence Interval
groups
  1. description
    Standard VCR dosing (1.5 mg/m\^2, max 2mg)
    id
    OG000
    title
    Regimen A
  2. description
    Intensive VCR dosing (2 mg/m\^2, max 2.5 mg)
    id
    OG001
    title
    Regimen B
param Type
NUMBER
population Description
The percentage of patients (pts) who were event free at 3 years among those with isolated BM or combined BM relapse \>= 36 months. Pts with MRD \<0.01% at the end of Block 1 (MRD \< 0.01% BL1); MRD \>= 0.01% at the end of Block 1 (MRD\>= 0.01% BL1); MRD \< 0.01% at the end of Block 3 (MRD \< 0.01% BL3);MRD \>=0.01% at the end of Block 3.
reporting Status
POSTED
time Frame
3 years
title
Event Free Survival (EFS)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice