NCT01332968 · OUTCOME

Overall Survival (Follicular Lymphoma Population)

A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM) · Source last updated 2022-08-11

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

Measure: NUMBER
Unit: percentage of participants with event
Interval / dispersion: Not reported
Time frame: Baseline up to 10 years

What was measured

Overall survival in the follicular lymphoma population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event.

Analysis population: The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.

Groups in this outcome

Rituximab+Chemotherapy

Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.

Obinutuzumab+Chemotherapy

Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.

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+Chemotherapy	601
Obinutuzumab+Chemotherapy	601

Reported measurements

Source class 1

Values in percentage of participants with event · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab+Chemotherapy	14.3	Not reported	Not reported	Not reported	Not reported
Obinutuzumab+Chemotherapy	12.6	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
0.63
ci Pct Value
95
ci Upper Limit
1.18
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.3577
param Type
Hazard Ratio (HR)
param Value
0.86
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.63
ci Pct Value
95
ci Upper Limit
1.18
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.3577
param Type
Hazard Ratio (HR)
param Value
0.86
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
value
14.3
group Id
OG001
value
12.6

denoms

counts
group Id
OG000
value
601
group Id
OG001
value
601
units
Participants

description

groups

description
Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
id
OG000
title
Rituximab+Chemotherapy
description
Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
id
OG001
title
Obinutuzumab+Chemotherapy

param Type

NUMBER

population Description

The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.

reporting Status

POSTED

time Frame

Baseline up to 10 years

title

Overall Survival (Follicular Lymphoma Population)

type

SECONDARY

unit Of Measure

percentage of participants with event

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Preserved source evidence · Independent clinical review pending · Not medical advice