NCT01332968 · OUTCOME

Complete Response (Overall Study Population), IRC-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

Percentage of participants with complete response in the overall study population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.

Analysis population: The ITT population defined as all randomized participants 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	699
Obinutuzumab+Chemotherapy	702

Reported measurements

Without PET

Analysis denominator · Participants

Group	Source count
Rituximab+Chemotherapy	184
Obinutuzumab+Chemotherapy	190

Values in percentage of participants with event · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab+Chemotherapy	26.3	Not reported	Not reported	Not reported	Not reported
Obinutuzumab+Chemotherapy	27.1	Not reported	Not reported	Not reported	Not reported

With PET

Analysis denominator · Participants

Group	Source count
Rituximab+Chemotherapy	196
Obinutuzumab+Chemotherapy	223

Values in percentage of participants with event · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab+Chemotherapy	59.4	Not reported	Not reported	Not reported	Not reported
Obinutuzumab+Chemotherapy	69.5	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
-4.0
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.5
group Description
Without PET
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.80
param Type
Absolute difference in %
param Value
0.7
statistical Method
Log Rank
ci Lower Limit
2.6
ci Pct Value
95
ci Upper Limit
17.6
group Description
With PET
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.009
param Type
Absolute difference in %
param Value
10.1
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
-4.0
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.5
group Description
Without PET
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.80
param Type
Absolute difference in %
param Value
0.7
statistical Method
Log Rank
ci Lower Limit
2.6
ci Pct Value
95
ci Upper Limit
17.6
group Description
With PET
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.009
param Type
Absolute difference in %
param Value
10.1
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
value
26.3
group Id
OG001
value
27.1
denoms
counts
group Id
OG000
value
184
group Id
OG001
value
190
units
Participants
title
Without PET
categories
measurements
group Id
OG000
value
59.4
group Id
OG001
value
69.5
denoms
counts
group Id
OG000
value
196
group Id
OG001
value
223
units
Participants
title
With PET

denoms

counts
group Id
OG000
value
699
group Id
OG001
value
702
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 ITT population defined as all randomized participants 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

Complete Response (Overall Study Population), IRC-Assessed

type

SECONDARY

unit Of Measure

percentage of participants with event

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

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