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NCT01938001 · OUTCOME

Kaplan-Meier Estimate of Overall Survival (OS)

Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma) · Source last updated 2023-02-22

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization to death due to any cause (Average of 55.71 months and a maximum up to 95.2 months)

What was measured

Overall survival was defined as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.

Analysis population: The ITT population is defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.

Groups in this outcome

Rituximab + Lenalidomide (R^2)

Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.

Rituximab + Placebo

Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 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
Rituximab + Lenalidomide (R^2)178
Rituximab + Placebo180

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rituximab + Lenalidomide (R^2)NANot reportedNANAinsufficient number of participants with events
Rituximab + PlaceboNANot reportedNANAinsufficient number of participants with events

Source statistical analyses

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

  1. ci Lower Limit
    0.37
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.95
    group Description
    Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.59
Complete source fields
analyses
  1. ci Lower Limit
    0.37
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.95
    group Description
    Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.59
classes
  1. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        insufficient number of participants with events
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      178
    2. group Id
      OG001
      value
      180
    units
    Participants
description
Overall survival was defined as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
    id
    OG000
    title
    Rituximab + Lenalidomide (R^2)
  2. description
    Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
    id
    OG001
    title
    Rituximab + Placebo
param Type
MEDIAN
population Description
The ITT population is defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.
reporting Status
POSTED
time Frame
From date of randomization to death due to any cause (Average of 55.71 months and a maximum up to 95.2 months)
title
Kaplan-Meier Estimate of Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice