NCT01332968 · OUTCOME

Overall Response (Follicular Lymphoma Population), Investigator-Assessed

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 end of induction period (up to approximately 7 months)

What was measured

Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with and without PET. CR was defined as disappearance of all target lesions; PR was defined as \>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \>/= 50%. Overall Response (OR) = CR + PR.

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

Without PET

Analysis denominator · Participants

Group	Source count
Rituximab+Chemotherapy	519
Obinutuzumab+Chemotherapy	530

Values in percentage of participants with event · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab+Chemotherapy	86.4	Not reported	Not reported	Not reported	Not reported
Obinutuzumab+Chemotherapy	88.2	Not reported	Not reported	Not reported	Not reported

With PET

Analysis denominator · Participants

Group	Source count
Rituximab+Chemotherapy	242
Obinutuzumab+Chemotherapy	254

Values in percentage of participants with event · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab+Chemotherapy	81.2	Not reported	Not reported	Not reported	Not reported
Obinutuzumab+Chemotherapy	85.5	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
-2.02
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.68
group Description
Without PET
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.30
param Type
Absolute difference in %
param Value
1.8
statistical Method
Log Rank
ci Lower Limit
-1.8
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
10.5
group Description
With PET
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.17
param Type
Absolute difference in %
param Value
4.3
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
-2.02
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.68
group Description
Without PET
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.30
param Type
Absolute difference in %
param Value
1.8
statistical Method
Log Rank
ci Lower Limit
-1.8
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
10.5
group Description
With PET
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.17
param Type
Absolute difference in %
param Value
4.3
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
value
86.4
group Id
OG001
value
88.2
denoms
counts
group Id
OG000
value
519
group Id
OG001
value
530
units
Participants
title
Without PET
categories
measurements
group Id
OG000
value
81.2
group Id
OG001
value
85.5
denoms
counts
group Id
OG000
value
242
group Id
OG001
value
254
units
Participants
title
With PET

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 end of induction period (up to approximately 7 months)

title

Overall Response (Follicular Lymphoma Population), Investigator-Assessed

type

SECONDARY

unit Of Measure

percentage of participants with event

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