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NCT00061945 · OUTCOME

Disease-free Survival, for Only Complete Response Patients

Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia · Source last updated 2022-05-03

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
9 years 4 months

What was measured

Disease Free Survival (DFS) is defined as the time from a Complete Response (CR) until death or relapse. The date of last clinical assesment will be used as the censor date for patients with no death or relapse. The DFS will be estimated using the Kaplan-Meier method with confidence intervals presented.

Analysis population: All patients who received protocol treatment and had a complete response (CR) during treatment were included in this analysis. Phase I patients, who achieved complete response, were included with the phase II patients, who achieved complete response, for this analysis.

Groups in this outcome

Phase I - Alemtuzumab and Combination Chemotherapy

See detailed description or participant flow.

Phase II - Alemtuzumab and Combination Chemotherapy

See detailed description or participant flow.

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

Analysis denominator · Participants

GroupSource count
Phase I - Alemtuzumab and Combination Chemotherapy92
Phase II - Alemtuzumab and Combination Chemotherapy145

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase I - Alemtuzumab and Combination Chemotherapy58.6Not reported24.8103.8Not reported
Phase II - Alemtuzumab and Combination Chemotherapy19.8Not reported14.328.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24.8
        upper Limit
        103.8
        value
        58.6
      2. group Id
        OG001
        lower Limit
        14.3
        upper Limit
        28.4
        value
        19.8
denoms
  1. counts
    1. group Id
      OG000
      value
      92
    2. group Id
      OG001
      value
      145
    units
    Participants
description
Disease Free Survival (DFS) is defined as the time from a Complete Response (CR) until death or relapse. The date of last clinical assesment will be used as the censor date for patients with no death or relapse. The DFS will be estimated using the Kaplan-Meier method with confidence intervals presented.
dispersion Type
95% Confidence Interval
groups
  1. description
    See detailed description or participant flow.
    id
    OG000
    title
    Phase I - Alemtuzumab and Combination Chemotherapy
  2. description
    See detailed description or participant flow.
    id
    OG001
    title
    Phase II - Alemtuzumab and Combination Chemotherapy
param Type
MEDIAN
population Description
All patients who received protocol treatment and had a complete response (CR) during treatment were included in this analysis. Phase I patients, who achieved complete response, were included with the phase II patients, who achieved complete response, for this analysis.
reporting Status
POSTED
time Frame
9 years 4 months
title
Disease-free Survival, for Only Complete Response Patients
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice