NCT01938001 · OUTCOME

Kaplan Meier Estimate of Progression Free Survival Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC)

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 randomization of study drug up to disease progression or death, which occurred first; up to the data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).

What was measured

Progression-free survival (PFS) was defined as the time from date of randomization into the study to the first observation of documented disease progression or death due to any cause, whichever occurred first. PFS was based on the data from the IRC review using the modified 2007 International Working Group Response Criteria (IWGRC) using FDA censoring rules.

Analysis population: The ITT population was 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

Group	Source count
Rituximab + Lenalidomide (R^2)	178
Rituximab + Placebo	180

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Rituximab + Lenalidomide (R^2)	39.4	Not reported	22.9	NA	NA =Not enough events had occurred at the time of the data cut-off date
Rituximab + Placebo	14.1	Not reported	11.4	16.7	Not reported

Source statistical analyses

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

ci Lower Limit
0.34
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.62
estimate Comment
Hazard ratio and its confidence interval (CI) were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
< 0.0001
param Type
Hazard Ratio (HR)
param Value
0.46
statistical Comment
Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.34
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.62
estimate Comment
Hazard ratio and its confidence interval (CI) were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
< 0.0001
param Type
Hazard Ratio (HR)
param Value
0.46
statistical Comment
Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).
statistical Method
Log Rank

classes

categories
measurements
comment
NA =Not enough events had occurred at the time of the data cut-off date
group Id
OG000
lower Limit
22.9
upper Limit
NA
value
39.4
group Id
OG001
lower Limit
11.4
upper Limit
16.7
value
14.1

denoms

counts
group Id
OG000
value
178
group Id
OG001
value
180
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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)
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 was 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 randomization of study drug up to disease progression or death, which occurred first; up to the data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).

title

Kaplan Meier Estimate of Progression Free Survival Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC)

type

PRIMARY

unit Of Measure

months

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Preserved source evidence · Not medical advice