NCT01332968|CompletedPhase 3Results

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)

A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders

Hoffmann-La Roche ClinicalTrials.gov

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2 other identifiers

BO212232010-024132-41

Study Type

interventional

Target

1,401

Locations

18 countries

Sites

183

Timeline

RegisteredApr 2011

StartedJul 2011

CompletionJul 2021

Brief Summary

This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to rituximab (MabThera/Rituxan) with chemotherapy followed by obinutuzumab or rituximab maintenance in participants with untreated advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, participants achieving response (Complete response \[CR\] or partial response \[PR\]) will undergo a maintenance period continuing on the randomized antibody treatment alone every 2 months until disease progression for a total of 2 years. Anticipated time on study treatment is up to approximately 2.5 years. After maintenance or observation, participants will be followed for 5 years until progression. After progression, participants will be followed for new anti-lymphoma therapy and overall survival until the end of the study.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

1,401

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jul 2011

Longer than P75 for phase_3

Geographic Reach

18 countries

183 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.1 years study duration

First Submitted

Initial submission to the registry

April 8, 2011

Completed

3 days until next milestone

First Posted

Study publicly available on registry

April 11, 2011

Completed

3 months until next milestone

Study Start

First participant enrolled

July 6, 2011

Completed

4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

June 7, 2017

Completed

4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed

Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

4.6 years

First QC Date

April 8, 2011

Results QC Date

February 3, 2017

Last Update Submit

August 9, 2022

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).
Baseline up to data cut-off (up to approximately 4 years and 7 months)

Secondary Outcomes (30)

Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
Baseline up to final analysis (up to 10 years)
Progression-Free Survival in the Overall Study Population, Investigator-Assessed
Baseline up to data cut-off (up to approximately 5 years and 2 months)
Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed
Baseline up to data cut-off (up to approximately 5 years and 2 months)
Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)
Baseline up to data cut-off (up to approximately 5 years and 2 months)
Overall Response (Follicular Lymphoma Population), Investigator-Assessed
Baseline up to end of induction period (up to approximately 7 months)
+25 more secondary outcomes

Study Arms (2)

Rituximab+Chemotherapy

ACTIVE COMPARATOR

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.

Drug: CyclophosphamideDrug: DoxorubicinDrug: VincristineDrug: PrednisoneDrug: BendamustineDrug: Rituximab

Obinutuzumab+Chemotherapy

EXPERIMENTAL

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.

Drug: ObinutuzumabDrug: CyclophosphamideDrug: DoxorubicinDrug: VincristineDrug: PrednisoneDrug: Bendamustine

Interventions

ObinutuzumabDRUG

Obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion will be administered on Day 1, 8, and 15 of Cycle 1 and then on Day 1 of each subsequent cycle during induction period and obinutuzumab 1000 mg IV infusion every 2 months during maintenance period.

Also known as: GA101; RO5072759

Obinutuzumab+Chemotherapy

CyclophosphamideDRUG

Cyclophosphamide 750 mg/m\^2 IV will be administered on Day 1 of each cycle during induction period.