Trial · NCT01332968
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)
NCT01332968, Phase 3, Completed, Hoffmann-La Roche; results first posted 2017-06-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT01332968. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01332968
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT01332968
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,401 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Obinutuzumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Bendamustine, Rituximab
- First posted
- 2011-04-11
- Last updated
- 2022-08-11
- Other registries' IDs
- eudract:2010-024132-41
- Results first posted
- 2017-06-07
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed | Baseline up to data cut-off (up to approximately 4 years and 7 months) | 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). |
| Secondary | Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed | Baseline up to final analysis (up to 10 years) | 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). |
| Secondary | 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 in the overall study population 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 CT/MRI. |
| Secondary | 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 in the 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 IRC 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 CT/MRI. In the first 170 patients with follicular lymphoma, an FDG-PET was mandatory where a PET scanner was available. |
| Secondary | 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) | Progression-free survival in the overall study population 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 IRC 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 CT/MRI. |
| Secondary | Overall Response (Follicular Lymphoma Population), Investigator-Assessed | Baseline up to end of induction period (up to approximately 7 months) | 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. |
| Secondary | Overall Response (Overall Study Population), Investigator-Assessed | Baseline up to end of induction period (up to approximately 7 months) | Overall response in the overall study population was defined as percentage of participants with partial response (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 or without positron emission tomography (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. |
| Secondary | Complete Response (Follicular Lymphoma Population), Investigator-Assessed | Baseline up to end of induction period (up to approximately 7 months) | Percentage of participants with complete response in the follicular lymphoma population was 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 or without PET. CR was defined as disappearance of all target lesions. |
| Secondary | Complete Response (Overall Study Population), Investigator-Assessed | Baseline up to end of induction period (up to approximately 7 months) | Percentage of participants with complete response in the overall study population was 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 or without PET. CR was defined as disappearance of all target lesions. |
| Secondary | Overall Response (Follicular Lymphoma Population), IRC-Assessed | Baseline up to end of induction period (up to approximately 7 months) | Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR 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; 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. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed | Baseline up to data cut-off (up to approximately 4 years and 7 months) | The intent-to-treat follicular lymphoma population (FL ITT), 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. | percentage of participants with event | NUMBER |
| SECONDARY | Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed | Baseline up to final analysis (up to 10 years) | The FL ITT population was 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. | percentage of participants with event | NUMBER |
| SECONDARY | Progression-Free Survival in the Overall Study Population, Investigator-Assessed | Baseline up to data cut-off (up to approximately 5 years and 2 months) | The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received. | percentage of participants with event | NUMBER |
| SECONDARY | Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed | Baseline up to data cut-off (up to approximately 5 years and 2 months) | 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. | percentage of participants with event | NUMBER |
| SECONDARY | 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) | The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received. | percentage of participants with event | NUMBER |
| SECONDARY | Overall Response (Follicular Lymphoma Population), Investigator-Assessed | Baseline up to end of induction period (up to approximately 7 months) | 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. | percentage of participants with event | NUMBER |
| SECONDARY | Overall Response (Overall Study Population), Investigator-Assessed | Baseline up to end of induction period (up to approximately 7 months) | The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received. | percentage of participants with event | NUMBER |
| SECONDARY | Complete Response (Follicular Lymphoma Population), Investigator-Assessed | Baseline up to end of induction period (up to approximately 7 months) | 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. | percentage of participants with event | NUMBER |
| SECONDARY | Complete Response (Overall Study Population), Investigator-Assessed | Baseline up to end of induction period (up to approximately 7 months) | The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received. | percentage of participants with event | NUMBER |
| SECONDARY | Overall Response (Follicular Lymphoma Population), IRC-Assessed | Baseline up to end of induction period (up to approximately 7 months) | 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. | percentage of participants with event | NUMBER |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group169
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed | Rituximab+Chemotherapy | 24.0 | percentage of participants with event | ||
| Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed | Obinutuzumab+Chemotherapy | 16.8 | percentage of participants with event | ||
| Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed | Rituximab+Chemotherapy | 40.6 | percentage of participants with event | ||
| Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed | Obinutuzumab+Chemotherapy | 34.3 | percentage of participants with event | ||
| Progression-Free Survival in the Overall Study Population, Investigator-Assessed | Rituximab+Chemotherapy | 41.5 | percentage of participants with event | ||
| Progression-Free Survival in the Overall Study Population, Investigator-Assessed | Obinutuzumab+Chemotherapy | 34.8 | percentage of participants with event | ||
| Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed | Rituximab+Chemotherapy | 23.5 | percentage of participants with event | ||
| Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed | Obinutuzumab+Chemotherapy | 18.0 | percentage of participants with event | ||
| Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC) | Rituximab+Chemotherapy | 24.6 | percentage of participants with event | ||
| Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC) | Obinutuzumab+Chemotherapy | 18.4 | percentage of participants with event |
1 to 10 of 169Source ClinicalTrials.gov
See all 169 results by groupParticipant flow72
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Period | STARTED | Rituximab+Chemotherapy - Induction Period | 699 | |
| Induction Period | STARTED | Obinutuzumab+Chemotherapy - Induction Period | 702 | |
| Induction Period | STARTED | Rituximab+Chemotherapy - Maintenance Period | 0 | |
| Induction Period | STARTED | Obinutuzumab+Chemotherapy - Maintenance Period | 0 | |
| Induction Period | STARTED | Rituximab+Chemotherapy - Observation Period | 0 | |
| Induction Period | STARTED | Obinutuzumab+Chemotherapy - Observation Period | 0 | |
| Induction Period | STARTED | Rituximab+Chemotherapy - Follow-Up Period | 0 | |
| Induction Period | STARTED | Obinutuzumab+Chemotherapy - Follow-Up Period | 0 | |
| Induction Period | COMPLETED | Rituximab+Chemotherapy - Induction Period | 641 | |
| Induction Period | COMPLETED | Obinutuzumab+Chemotherapy - Induction Period | 646 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 participant flowAdverse events1,020
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Rituximab+Chemotherapy | 72 | 692 | 95 |
| other | ANAEMIA | Blood and lymphatic system disorders | Obinutuzumab+Chemotherapy | 75 | 698 | 88 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Rituximab+Chemotherapy | 91 | 692 | 267 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Obinutuzumab+Chemotherapy | 87 | 698 | 222 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Rituximab+Chemotherapy | 307 | 692 | 777 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Obinutuzumab+Chemotherapy | 348 | 698 | 885 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Rituximab+Chemotherapy | 52 | 692 | 79 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Obinutuzumab+Chemotherapy | 90 | 698 | 150 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Rituximab+Chemotherapy | 78 | 692 | 95 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Obinutuzumab+Chemotherapy | 69 | 698 | 84 |
1 to 10 of 1,020Source ClinicalTrials.gov
See all 1,020 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab+Chemotherapy | 111 | 692 |
| Total, all-cause mortality | Obinutuzumab+Chemotherapy | 104 | 698 |
| Total, other adverse events | Rituximab+Chemotherapy | 675 | 692 |
| Total, other adverse events | Obinutuzumab+Chemotherapy | 690 | 698 |
| Total, serious adverse events | Rituximab+Chemotherapy | 309 | 692 |
| Total, serious adverse events | Obinutuzumab+Chemotherapy | 361 | 698 |
Source ClinicalTrials.gov
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rituximab+Chemotherapy vs Obinutuzumab+Chemotherapy: deaths from any cause | Trial comparisons |
| Rituximab+Chemotherapy vs Obinutuzumab+Chemotherapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01332968
GET https://conductscience.org/api/trials/v1/NCT01332968/registered?page=2