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NCT00281918 · OUTCOME

Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response

Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia · Source last updated 2013-09-19

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
Median observation time was approximately 66.4 months

What was measured

CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.

Analysis population: Intent-to-treat population included all randomized participants.

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 intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.

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)409
Fludarabine+Cyclophosphamide+Rituximab (FCR)408

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Fludarabine+Cyclophosphamide (FC)72.4Not reported67.876.7Not reported
Fludarabine+Cyclophosphamide+Rituximab (FCR)85.8Not reported82.089.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.62
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.28
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <.0001
    param Type
    Odds Ratio (OR)
    param Value
    2.30
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    1.62
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.28
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <.0001
    param Type
    Odds Ratio (OR)
    param Value
    2.30
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        67.8
        upper Limit
        76.7
        value
        72.4
      2. group Id
        OG001
        lower Limit
        82.0
        upper Limit
        89.0
        value
        85.8
denoms
  1. counts
    1. group Id
      OG000
      value
      409
    2. group Id
      OG001
      value
      408
    units
    Participants
description
CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.
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 intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
    id
    OG001
    title
    Fludarabine+Cyclophosphamide+Rituximab (FCR)
param Type
NUMBER
population Description
Intent-to-treat population included all randomized participants.
reporting Status
POSTED
time Frame
Median observation time was approximately 66.4 months
title
Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice