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NCT00090051 · OUTCOME

Final Analysis: Time to Event-Free Survival Event

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
Median observation time was approximately 5 years

What was measured

Event free survival (EFS) was defined as the time from the day of randomization to the date of first EFS event: documented disease progression, relapse after response, start of a new treatment or death from any cause.

Analysis population: Participants from the Intent-to-treat population, all randomized participants, who had an EFS event. Participants who did not have an ESF event at the time of the final analysis were censored at the date of the last contact.

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)218
Fludarabine+Cyclophosphamide+Rituximab (FCR)207

Reported measurements

Source class 1
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Fludarabine+Cyclophosphamide (FC)630.0Not reported548747Not reported
Fludarabine+Cyclophosphamide+Rituximab (FCR)932.0Not reported7771187Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.79
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.65
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.79
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.65
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        548
        upper Limit
        747
        value
        630.0
      2. group Id
        OG001
        lower Limit
        777
        upper Limit
        1187
        value
        932.0
denoms
  1. counts
    1. group Id
      OG000
      value
      218
    2. group Id
      OG001
      value
      207
    units
    Participants
description
Event free survival (EFS) was defined as the time from the day of randomization to the date of first EFS event: documented disease progression, relapse after response, start of a new treatment or death from any cause.
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
Participants from the Intent-to-treat population, all randomized participants, who had an EFS event. Participants who did not have an ESF event at the time of the final analysis were censored at the date of the last contact.
reporting Status
POSTED
time Frame
Median observation time was approximately 5 years
title
Final Analysis: Time to Event-Free Survival Event
type
SECONDARY
unit Of Measure
Days

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Preserved source evidence · Not medical advice