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NCT00090051 · OUTCOME

Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Mean observation time at time of analysis was approximately 26 months

What was measured

Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause (PFS events), whichever came first. Patients without a PFS event were censored at their last tumor assessment date.

Analysis population: Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.

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)276
Fludarabine+Cyclophosphamide+Rituximab (FCR)276

Reported measurements

Patients with event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fludarabine+Cyclophosphamide (FC)148Not reportedNot reportedNot reportedNot reported
Fludarabine+Cyclophosphamide+Rituximab (FCR)137Not reportedNot reportedNot reportedNot reported
Patients without events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fludarabine+Cyclophosphamide (FC)128Not reportedNot reportedNot reportedNot reported
Fludarabine+Cyclophosphamide+Rituximab (FCR)139Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        148
      2. group Id
        OG001
        value
        137
    title
    Patients with event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        128
      2. group Id
        OG001
        value
        139
    title
    Patients without events
denoms
  1. counts
    1. group Id
      OG000
      value
      276
    2. group Id
      OG001
      value
      276
    units
    Participants
description
Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause (PFS events), whichever came first. Patients without a PFS event were censored at their last tumor assessment date.
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
NUMBER
population Description
Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.
reporting Status
POSTED
time Frame
Mean observation time at time of analysis was approximately 26 months
title
Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice