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NCT02048813 · OUTCOME

Overall Survival (OS) Rate at 3 Years

Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma · Source last updated 2026-08-28

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

Measure
NUMBER
Unit
Proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
Assessed every 3 months until progression; after progression, assessed every 3 months for first 2 years, every 6 months for years 3-5, up to 4 years and 8 months

What was measured

Overall survival was defined as time from randomization to death from any cause or date last known alive. Overall survival rate at 3 years was estimated using the method of Kaplan-Meier.

Analysis population: All randomized patients were included in this analysis.

Groups in this outcome

Arm A (Ibrutinib, Rituximab)

Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.

Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)

Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Arm A (Ibrutinib, Rituximab)354
Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)175

Reported measurements

Source class 1
Values in Proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Ibrutinib, Rituximab)0.988Not reported0.9761.00Not reported
Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)0.915Not reported0.8620.970Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.05
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.54
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.17
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.05
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.54
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.17
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.976
        upper Limit
        1.00
        value
        0.988
      2. group Id
        OG001
        lower Limit
        0.862
        upper Limit
        0.970
        value
        0.915
denoms
  1. counts
    1. group Id
      OG000
      value
      354
    2. group Id
      OG001
      value
      175
    units
    Participants
description
Overall survival was defined as time from randomization to death from any cause or date last known alive. Overall survival rate at 3 years was estimated using the method of Kaplan-Meier.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.
    id
    OG000
    title
    Arm A (Ibrutinib, Rituximab)
  2. description
    Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.
    id
    OG001
    title
    Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
param Type
NUMBER
population Description
All randomized patients were included in this analysis.
reporting Status
POSTED
time Frame
Assessed every 3 months until progression; after progression, assessed every 3 months for first 2 years, every 6 months for years 3-5, up to 4 years and 8 months
title
Overall Survival (OS) Rate at 3 Years
type
SECONDARY
unit Of Measure
Proportion of participants

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Preserved source evidence · Not medical advice