Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01996865 · OUTCOME

Progression Free Survival (PFS)

Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma. · Source last updated 2025-07-10

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

Measure
MEDIAN
Unit
Weeks
Interval / dispersion
95% Confidence Interval
Time frame
From the first dose date of maintenance therapy to objective disease progression or death from any cause, whichever occurs first (up to approximately 432 weeks)

What was measured

Progression free survival (PFS) is defined as the time from the date of first dose of maintenance therapy to the date of the first objective documentation of tumor progression or death due to any cause. Analysis was based on Kaplan Meier estimates. The PFS events were determined using a modification of the IWG 1999 criteria.

Analysis population: All randomized participants in Arm A and Arm B, as prespecified in the protocol

Groups in this outcome

Arm A: Lenalidomide + Rituximab

Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.

Arm B: Rituximab

Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29

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: Lenalidomide + Rituximab135
Arm B: Rituximab132

Reported measurements

Source class 1
Values in Weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Lenalidomide + Rituximab263.1Not reported166.1NAUpper limit not calculated due to insufficient number of events.
Arm B: Rituximab229.1Not reported173.7NAUpper limit not calculated due to insufficient number of events.

Source statistical analyses

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

  1. ci Lower Limit
    0.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.2
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.3296
    param Type
    Hazard Ratio (HR)
    param Value
    0.8
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.2
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.3296
    param Type
    Hazard Ratio (HR)
    param Value
    0.8
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. comment
        Upper limit not calculated due to insufficient number of events.
        group Id
        OG000
        lower Limit
        166.1
        upper Limit
        NA
        value
        263.1
      2. comment
        Upper limit not calculated due to insufficient number of events.
        group Id
        OG001
        lower Limit
        173.7
        upper Limit
        NA
        value
        229.1
denoms
  1. counts
    1. group Id
      OG000
      value
      135
    2. group Id
      OG001
      value
      132
    units
    Participants
description
Progression free survival (PFS) is defined as the time from the date of first dose of maintenance therapy to the date of the first objective documentation of tumor progression or death due to any cause. Analysis was based on Kaplan Meier estimates. The PFS events were determined using a modification of the IWG 1999 criteria.
dispersion Type
95% Confidence Interval
groups
  1. description
    Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
    id
    OG000
    title
    Arm A: Lenalidomide + Rituximab
  2. description
    Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29
    id
    OG001
    title
    Arm B: Rituximab
param Type
MEDIAN
population Description
All randomized participants in Arm A and Arm B, as prespecified in the protocol
reporting Status
POSTED
time Frame
From the first dose date of maintenance therapy to objective disease progression or death from any cause, whichever occurs first (up to approximately 432 weeks)
title
Progression Free Survival (PFS)
type
PRIMARY
unit Of Measure
Weeks

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

Preserved source evidence · Not medical advice