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NCT00090051 · OUTCOME

Disease-free Survival (DFS)

FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients · Source last updated 2017-08-01

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
95% Confidence Interval
Time frame
Mean observation time at time of analysis was approximately 26 months

What was measured

Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause. Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.

Analysis population: Intent-to-treat (ITT) population for patients with a Best Overall Response of Complete Response.

Groups in this outcome

Fludarabine+Cyclophosphamide (FC)

Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.

Fludarabine+Cyclophosphamide+Rituximab (FCR)

Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.

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

Analysis denominator · Participants

GroupSource count
Fludarabine+Cyclophosphamide (FC)36
Fludarabine+Cyclophosphamide+Rituximab (FCR)67

Reported measurements

Source class 1
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Fludarabine+Cyclophosphamide (FC)1285Not reported791NAThe upper limit could not be estimated due to too low number of events at time of analysis.
Fludarabine+Cyclophosphamide+Rituximab (FCR)1204Not reported938NAThe upper limit could not be estimated due to too low number of events at time of analysis.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.8842
    statistical Comment
    non-stratified
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.8842
    statistical Comment
    non-stratified
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The upper limit could not be estimated due to too low number of events at time of analysis.
        group Id
        OG000
        lower Limit
        791
        upper Limit
        NA
        value
        1285
      2. comment
        The upper limit could not be estimated due to too low number of events at time of analysis.
        group Id
        OG001
        lower Limit
        938
        upper Limit
        NA
        value
        1204
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    2. group Id
      OG001
      value
      67
    units
    Participants
description
Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause. Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.
dispersion Type
95% Confidence Interval
groups
  1. description
    Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
    id
    OG000
    title
    Fludarabine+Cyclophosphamide (FC)
  2. description
    Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
    id
    OG001
    title
    Fludarabine+Cyclophosphamide+Rituximab (FCR)
param Type
MEDIAN
population Description
Intent-to-treat (ITT) population for patients with a Best Overall Response of Complete Response.
reporting Status
POSTED
time Frame
Mean observation time at time of analysis was approximately 26 months
title
Disease-free Survival (DFS)
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice