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)

• ClinicalTrials.gov Identifier: NCT01332968
• Recruitment Status: Completed
• First Posted: April 11, 2011
• Results First Posted: June 7, 2017
• Last Update Posted: August 11, 2022
• Sponsor: Hoffmann-La Roche
• Collaborators: German Low Grade Lymphoma Study Group; Institute of Cancer Research, United Kingdom
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-Hodgkin's Lymphoma	Drug: Obinutuzumab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Bendamustine; Drug: Rituximab	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1401 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: July 6, 2011
• Actual Primary Completion Date: February 1, 2016
• Actual Study Completion Date: July 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Drug: Cyclophosphamide; Cyclophosphamide 750 mg/m^2 IV will be administered on Day 1 of each cycle during induction period.; Drug: Doxorubicin; Doxorubicin 50 mg/m^2 IV will be administered on Day 1 of each cycle during induction period.; Drug: Vincristine; Vincristine 1.4 mg/m^2 (maximum 2 mg) IV will be administered on Day 1 of each cycle during induction period.; Drug: Prednisone; Prednisone 100 mg (or equivalent prednisolone or methylprednisolone) will be administered orally on Days 1-5 of each cycle during induction period.; Drug: Bendamustine; Bendamustine 90 mg/m^2 IV infusion will be administered on Days 1 and 2 of each cycle during induction period.; Drug: Rituximab; Rituximab 375 milligrams per square meter (mg/m^2) IV infusion will be administered on Day 1 of each cycle during induction period and rituximab 375 mg/m^2 every 2 months during maintenance period.; Other Name: MabThera/Rituxan
Experimental: 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.	Drug: Obinutuzumab; 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.; Other Name: GA101; RO5072759; Drug: Cyclophosphamide; Cyclophosphamide 750 mg/m^2 IV will be administered on Day 1 of each cycle during induction period.; Drug: Doxorubicin; Doxorubicin 50 mg/m^2 IV will be administered on Day 1 of each cycle during induction period.; Drug: Vincristine; Vincristine 1.4 mg/m^2 (maximum 2 mg) IV will be administered on Day 1 of each cycle during induction period.; Drug: Prednisone; Prednisone 100 mg (or equivalent prednisolone or methylprednisolone) will be administered orally on Days 1-5 of each cycle during induction period.; Drug: Bendamustine; Bendamustine 90 mg/m^2 IV infusion will be administered on Days 1 and 2 of each cycle during induction period.

Outcome Measures

Primary Outcome Measures :

1. Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed [ Time Frame: 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 Outcome Measures :

1. Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed [ Time Frame: 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).
2. Progression-Free Survival in the Overall Study Population, Investigator-Assessed [ Time Frame: 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.
3. Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed [ Time Frame: 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.
4. Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC) [ Time Frame: 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.
5. Overall Response (Follicular Lymphoma Population), Investigator-Assessed [ Time Frame: 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.
6. Overall Response (Overall Study Population), Investigator-Assessed [ Time Frame: 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.
7. Complete Response (Follicular Lymphoma Population), Investigator-Assessed [ Time Frame: 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.
8. Complete Response (Overall Study Population), Investigator-Assessed [ Time Frame: 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.
9. Overall Response (Follicular Lymphoma Population), IRC-Assessed [ Time Frame: 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.
10. Overall Response (Overall Study Population), IRC-Assessed [ Time Frame: 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 PR or 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.
11. Complete Response (Follicular Lymphoma Population), IRC-Assessed [ Time Frame: 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 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.
12. Complete Response (Overall Study Population), IRC-Assessed [ Time Frame: 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 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.
13. Overall Survival (Follicular Lymphoma Population) [ Time Frame: Baseline up to 10 years ]
    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.
14. Overall Survival (Overall Study Population) [ Time Frame: Baseline up to data cut-off (up to approximately 5 years and 2 months) ]
    Overall survival in the overall study 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.
15. Event-Free Survival (Follicular Lymphoma Population) [ Time Frame: Baseline up to 10 years ]
    Event-free survival in the follicular lymphoma population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse 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. Reported is the percentage of participants with an event.
16. Event-Free Survival (Overall Study Population) [ Time Frame: Baseline up to data cut-off (up to approximately 5 years and 2 months) ]
    Event-free survival in the overall study population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse 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. Reported is the percentage of participants with event.
17. Disease-Free Survival (Follicular Lymphoma Population) [ Time Frame: From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months) ]
    Disease-free survival in the follicular lymphoma population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma (RRCML). Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse 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. Reported is the percentage of participants with event.
18. Disease-Free Survival (Overall Study Population) [ Time Frame: From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months) ]
    Disease-free survival in the overall study population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse 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. Reported is the percentage of participants with event.
19. Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed [ Time Frame: From first occurrence of documented CR or PR to data cut-off (up to approximately 5 years and 2 months) ]
    DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. 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%. Progression/relapse 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.
20. Duration of Response (DOR) (Overall Study Population), Investigator-Assessed [ Time Frame: From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months) ]
    DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. 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%. Progression/relapse 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.
21. Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population) [ Time Frame: Baseline up to 10 years ]
    Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event.
22. Time to Next Anti-Lymphoma Treatment (Overall Study Population) [ Time Frame: Baseline up to data cut-off (up to approximately 5 years and 2 months) ]
    Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event.
23. Percentage of Participants With Adverse Events [ Time Frame: Baseline up to 10 years ]
    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
24. Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) [ Time Frame: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months) ]
    FACT-G consists of the following 4 FACT-Lym sub-questionnaires: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24) and Functional Well-being (range: 0-28). Higher scores indicate better outcomes. A positive change from baseline indicates improvement. Maint = Maintenance period.
25. Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population) [ Time Frame: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months) ]
    The FACT-Lym TOI Score for the follicular lymphoma population was derived from the following 3 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym TOI Score is the sum of the 3 individual subscales (range 0-116). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.
26. Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population) [ Time Frame: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months) ]
    The FACT-Lym Individual Subscale Lymphoma Score for the follicular lymphoma population was derived from the Lymphoma subscale questionnaire (range: 0-60). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.
27. Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population) [ Time Frame: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months) ]
    The FACT-Lym Total Score for the follicular lymphoma population was derived from the following 5 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24),Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym Total Score is the sum of all 5 individual subscales (range 0-168). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.
28. Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase [ Time Frame: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months) ]
    The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Completion (Compl) includes completion visit and early termination visit. Maintenance/Observation is indicated as Maint/Obs.
29. Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase [ Time Frame: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months) ]
    The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1 Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs. Completion includes completion visit and early termination visit.
30. Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase [ Time Frame: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 after Day 1 of last induction cycle, Follow-up: every year for up to data cut-off (up to 5 years and 2 months) ]
    The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs in data categories. Completion includes completion visit and early termination visit.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Cluster of differentiation 20 (CD20)-positive indolent B-cell non-Hodgkin's lymphoma (follicular lymphoma or splenic, nodal or extranodal marginal zone lymphoma)
• Stage III or IV disease, or Stage II bulky disease (defined as tumor diameter greater than or equal to [>/=] 7 centimeters [cm])
• For participants with follicular lymphoma: requirement for treatment according to Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
• For participants with symptomatic splenic, nodal, or non-gastric extranodal marginal zone lymphoma: disease that is de novo or has relapsed following local therapy (i.e. surgery or radiotherapy) and requires therapy as assessed by the investigator
• At least one bi-dimensionally measurable lesion (greater than [>] 2 cm in its largest dimension by computed tomography [CT] scan or magnetic resonance imaging [MRI])
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• Adequate hematologic function

Exclusion Criteria:

• Central nervous system lymphoma, leptomeningeal lymphoma, or histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
• Grade 3b follicular lymphoma, small lymphocytic lymphoma or Waldenström's macroglobulinaemia
• Ann Arbor Stage I disease
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
• Known hypersensitivity to any of the study drugs or sensitivity to murine products, or history of sensitivity to mannitol
• For participants with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma with chemotherapy, immunotherapy, or radiotherapy
• For participants with non-follicular lymphoma: prior treatment with chemotherapy or immunotherapy
• Regular treatment with corticosteroids during the 4 weeks prior to the start of Cycle 1
• Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
• For participants who will be receiving cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP): left ventricular ejection fraction (LVEF) less than (<) 50% by multiple-gated acquisition (MUGA) scan or echocardiogram
• History of prior other malignancy with the exception of curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study
• Known active infection, or major episode of infection within 4 week prior to the start of Cycle 1
• Vaccination with a live vaccine within 28 days prior to randomization
• Recent major surgery (within 4 weeks prior to start of Cycle 1), other than for diagnosis
• Abnormal laboratory values as defined by protocol for creatinine, creatinine clearance, aspartate transaminase (AST) or alanine transaminase (ALT), total bilirubin, international normalized ration (INR), partial thromboplastin time (PTT) or activated partial thromboplastin time (aPPT), unless these abnormalities are due to underlying lymphoma
• Positive test results for human immunodeficiency virus (HIV), human T-lymphotropic virus 1 (HTLV1), hepatitis C or chronic hepatitis B
• Pregnant or lactating women
• Life expectancy <12 months
• Participation in another clinical trial with drug intervention within 28 days prior to start of Cycle 1 and during study

Contacts and Locations

Locations

United States, Arkansas

Highlands Oncology Group

Springdale, Arkansas, United States, 72762

United States, California

The Regents of the University of California; Office of Research

Irvine, California, United States, 92697

United States, Idaho

Kootenai Cancer Center

Post Falls, Idaho, United States, 83854

United States, Illinois

Illinois Cancer Care, P.C. - Galesburg

Galesburg, Illinois, United States, 61401

United States, Iowa

Siouxland Hematology/Oncology

Sioux City, Iowa, United States, 51101

United States, Kansas

University of Kansas; Medical Center & Medical pavilion

Westwood, Kansas, United States, 66205

Cancer Center of Kansas

Wichita, Kansas, United States, 67214-3728

United States, Missouri

Mercy Medical Research Institute

Springfield, Missouri, United States, 65807

United States, Montana

MT Cancer Inst Fndtn; MT Can Spec

Missoula, Montana, United States, 59802

United States, New Mexico

San Juan Oncology Associates

Farmington, New Mexico, United States, 87401

United States, Oregon

Providence St. Vincent Medical Center

Portland, Oregon, United States, 97225

United States, Washington

Northwest Medical Specialties

Tacoma, Washington, United States, 98405

Australia, New South Wales

Concord Repatriation General Hospital; Haematology

Sydney, New South Wales, Australia, 2139

Westmead Hospital; Haematology

Sydney, New South Wales, Australia, 2145

Australia, Queensland

Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

Woolloongabba, Queensland, Australia, 4102

Australia, Victoria

St Vincent'S Hospital; Haematology

Fitzroy, Victoria, Australia, 3065

Peter MacCallum Cancer Centre; Department of Haematology

Melbourne, Victoria, Australia, 3002

Austin and Repatriation Medical Centre; Cancer Services

Melbourne, Victoria, Australia, 3084

Monash Medical Centre; Haematology

Melbourne, Victoria, Australia, 3168

Australia, Western Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia, 6150

Belgium

UZ Gent

Gent, Belgium, 9000

AZ Groeninge

Kortrijk, Belgium, 8500

UZ Leuven Gasthuisberg

Leuven, Belgium, 3000

Canada, Alberta

Tom Baker Cancer Centre-Calgary

Calgary, Alberta, Canada, T2N 4N2

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Canada, New Brunswick

Dr. Georges L. Dumont University Hospital Centre

Moncton, New Brunswick, Canada, E1C 8X3

Canada, Ontario

Ottawa General Hospital

Ottawa, Ontario, Canada, K1H 8L6

North York General Hospital

Toronto, Ontario, Canada, M2K 1E1

Humber River Hospital

Toronto, Ontario, Canada, M3M 0B2

Toronto East General Hospital; Haematology/Oncology

Toronto, Ontario, Canada, M4C 3E7

Canada, Quebec

Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie

Greenfield Park, Quebec, Canada, J4V 2H1

China

Peking University First Hospital

Beijing City, China, 100034

Cancer Hospital Chinese Academy of Medical Sciences.

Beijing, China, 100021

Beijing Cancer Hospital

Beijing, China, 100142

General Hospital of Chinese PLA; Department of Hematology

Beijing, China, 100853

the First Hospital of Jilin University

Changchun, China, 130021

Fujian Medical University Union Hospital

Fuzhou City, China, 350001

Sun Yet-sen University Cancer Center

Guangzhou, China, 510060

Harbin Medical University Cancer Hospital

Harbin, China, 150081

Jiangsu Cancer Hospital

Nanjing City, China, 211100

Jiangsu Province Hospital

Nanjing, China, 210036

Fudan University Shanghai Cancer Center

Shanghai City, China, 200120

Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

Shanghai, China, 200025

Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center

Wuhan, China, 430023

Czechia

Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

Brno, Czechia, 625 00

Fn Hr. Kralove; IV. Interni Hematologicka Klinika

Hradec Kralove, Czechia, 500 05

Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK

Praha 2, Czechia, 128 08

Finland

Helsinki University Central Hospital; Dept of Oncology

Helsinki, Finland, 00250

France

Hotel Dieu; Medecine D

Angers, France, 49933

Hopital Augustin Morvan; Hematologie

Brest, France, 29609

Chu Estaing; Hematologie Clinique Adultes

Clermont Ferrand, France, 63003

Clinique Victor Hugo

LeMans, France, 72000

Hopital De La Conception; Hematologie Clinique

Marseille, France, 13005

Hopital Saint Eloi; Hematologie Oncologie Medicale

Montpellier, France, 34295

Hopital Saint Jean; Hematologie

Perpignan, France, 66046

Germany

Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch

Berlin, Germany, 14195

Klinikum Chemnitz gGmbH Krankenhaus Küchwald Klinik f.Innere Medizin III

Chemnitz, Germany, 09113

Städtisches Klinikum Dessau

Dessau-Roßlau, Germany, 06847

BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

Dresden, Germany, 01307

Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin

Dresden, Germany, 01307

HELIOS Klinikum Erfurt I.Medizinische Klinik

Erfurt, Germany, 99089

St.-Antonius-Hospital gGmbH; Klinik für Hämatologie und Onkologie

Eschweiler, Germany, 52249

Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

Essen, Germany, 45122

Klinik Johann Wolfgang von Goethe Uni; Medizinische Klinik II

Frankfurt, Germany, 60596

Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Hämatologie/Onkologie

Freiburg, Germany, 79106

Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

Greifswald, Germany, 17475

Uni Göttingen, Georg-August-Universität; Klinik für Hämatologie und Medizinische Onkologie

Göttingen, Germany, 37075

Kath. Krankenhaus Hagen gem. GmbH, St.-Josefs-Hospital; Klinik für Hämatologie und Onkologie

Hagen, Germany, 58097

Onkologische Schwerpunktpraxis Dres. Bernd Gaede, Hans-Ulrich Ehlers, Ulrike Rodewig u.w.

Hannover, Germany, 30171

Dres.Andreas Karcher und Stefan Fuxius

Heidelberg, Germany, 69115

Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V

Heidelberg, Germany, 69120

Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I

Homburg/Saar, Germany, 64421

Universitätsklinikum Jena; Klinik für Innere Medizin II

Jena, Germany, 07747

UKSH, Campus Kiel; Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie

Kiel, Germany, 24105

Institut für Versorgungsforschung in der Onkologie GbR Koblenz

Koblenz, Germany, 56068

Klinik der Uni zu Köln; Klinik für Innere Medizin

Köln, Germany, 50924

Tagesklinik Landshut; Hämatologie/Onkologie

Landshut, Germany, 84028

Gemeinschaftspraxis für Hämatologie und Onkologie

Lebach, Germany, 66822

Klinikum St.Georg gGmbH Klinik für Internistische Onkologie und Hämotologie

Leipzig, Germany, 04129

Klinikum der Stadt Ludwigshafen; Medizinische Klinik A

Ludwigshafen, Germany, 67063

Onkologische Gemeinschaftspraxis

Magdeburg, Germany, 39104

Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie

Magdeburg, Germany, 39120

Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik

Mainz, Germany, 55131

Mannheimer Onkologie Praxis Dres. Jürgen Brust Dieter Schuster

Mannheim, Germany, 68161

Klinikum Mannheim III. Medizinische Klinik

Mannheim, Germany, 68167

Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin

Mutlangen, Germany, 73557

St. Frankziskus Krankenhaus, Med. Klinik I; Klinik für Hämatologie,Onkologie u. Gastroenterologie

Mönchengladbach, Germany, 41063

Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III

München, Germany, 81377

Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)

München, Germany, 81675

Gemeinschaftspraxis Dr. med. Holger Klaproth

Neunkirchen/Saar, Germany, 66538

Pius-Hospital; Klinik fuer Haematologie und Onkologie

Oldenburg, Germany, 26121

Brüderkrankenhaus St. Josef

Paderborn, Germany, 33098

Prosper-Hospital, Medizinische Klinik I

Recklinghausen, Germany, 45659

Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / Hämatologie

Regensburg, Germany, 93049

Praxis für Hämatologie & Onkologie

Saarbruecken, Germany, 66113

Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie

Trier, Germany, 54292

Universität Tübingen; Med. Klinik; Innere Medizin I

Tübingen, Germany, 72076

Universtitätsklinikum Ulm; Klinik für Innere Medizin III

Ulm, Germany, 89081

Helios Dr. Horst Schmidt Kliniken; Klinik Innere MED III: Hämatologie, Onkologie, Palliativmedizin

Wiesbaden, Germany, 65199

Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker

Würzburg, Germany, 97080

Hungary

Semmelweis University, First Dept of Medicine

Budapest, Hungary, 1083

National Institute of Oncology, A Dept of Internal Medicine

Budapest, Hungary, 1122

University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology

Debrecen, Hungary, 4032

Petz Aladar Megyei Korhaz; Hematologia

Gyor, Hungary, 9024

University of Szeged, II Dept of Internal Medicine

Szeged, Hungary, 6720

Israel

Rambam Medical Center; Heamatology & Bone Marrow Transplantation

Haifa, Israel, 3109601

Beilinson Medical Center; Haematology

Petach Tikva, Israel, 4910000

Chaim Sheba Medical Center; Hematology BMT & CBB

Ramat-Gan, Israel, 5262100

Italy

Azienda Ospedaliera Universitaria di Modena

Modena, Emilia-Romagna, Italy, 41100

Az. Osp. S. Camillo Forlanini; Uo Ematologia E Trapianti Di Midollo Osseo

Roma, Lazio, Italy, 00152

ASST PAPA GIOVANNI XXIII; Ematologia

Bergamo, Lombardia, Italy, 24127

Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora

Milano, Lombardia, Italy, 20122

Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

Milano, Lombardia, Italy, 20162

Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

Rozzano, Lombardia, Italy, 20089

A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia

Torrette DI Ancona, Marche, Italy, 60020

Ospedale V. Cervello; U.O. Ematologia E Trapianti

Palermo, Sicilia, Italy, 90146

Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia

Padova, Veneto, Italy, 35128

Japan

Aichi Cancer Center Hospital; Hematology and Cell Therapy

Aichi, Japan, 464-8681

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital; Hematology & Oncology

Aichi, Japan, 466-8650

Nagoya City University Hospital; Hematology and Oncology

Aichi, Japan, 467-8602

Aomori Prefectural Central Hospital; Hematology

Aomori, Japan, 030-8553

Chiba Cancer Center;Hematology and Oncology

Chiba, Japan, 260-8717

National Cancer Center Hospital East;Hematology

Chiba, Japan, 277-8577

Shikoku Cancer Center; Hematology and Oncology

Ehime, Japan, 791-0280

National Hospital Organization Kyushu Cancer Center; Hematology

Fukuoka, Japan, 811-1395

Gunma University Hospital;Hematology

Gunma, Japan, 371-8511

Hiroshima University Hospital; Hematology

Hiroshima, Japan, 734-8551

Kobe City Medical Center General Hospital; Hematology

Hyogo, Japan, 650-0047

Hyogo Cancer Center; Department of hematology

Hyogo, Japan, 673-8558

Tokai University Hospital; Hematology

Kanagawa, Japan, 259-1193

Kumamoto University Hospital; Hematology Rheumatology and Clinical Immunology

Kumamoto, Japan, 860-8556

University Hospital, Kyoto Prefectural University of Medicine; Hematology

Kyoto, Japan, 602-8566

Tohoku University Hospital; Hematology and Immunology

Miyagi, Japan, 980-8574

Shinshu University Hospital; Hematology

Nagano, Japan, 390-8621

Niigata Cancer Center Hospital; Internal Medicine

Niigata, Japan, 951-8566

Matsushita Memorial Hospital; hematology

Osaka, Japan, 570-8540

Jichi Medical University Hospital; Hematology

Tochigi, Japan, 329-0498

National Cancer Center Hospital; Hematology

Tokyo, Japan, 104-0045

Toranomon Hospital; Hematology

Tokyo, Japan, 105-8470

The Cancer Institute Hospital of JFCR; Hematology Oncology

Tokyo, Japan, 135-8550

The Jikei University Daisan Hospital; Department of Clinical Oncology and Hematology

Tokyo, Japan, 201-8601

Russian Federation

FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

Moscow, Russian Federation, 115478

Regional Clinical Hospital N.A. Semashko; Hematology

Nizhny Novgorod, Russian Federation, 603126

Republican Clinical Hospital n.a. Baranov; Haematology

Petrozavodsk, Russian Federation, 185019

Spain

Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia

Badalona, Barcelona, Spain, 08915

Corporacio Sanitaria Parc Tauli; Servicio de Hematologia

Sabadell, Barcelona, Spain, 08208

Fundacion Hospital de Alcorcon; Servicio de Hematologia

Alcorcon, Madrid, Spain, 28922

Hospital de Basurto; Servicio de Hematologia

Bilbao, Vizcaya, Spain, 48013

Hospital Univ. 12 de Octubre; Servicio de Hematologia

Madrid, Spain, 28041

Hospital Universitario la Paz; Servicio de Hematologia

Madrid, Spain, 28046

Sweden

Sahlgrenska Universitetssjukhuset; Sektionen för hematologi och koagulation

Göteborg, Sweden, S-413 45

Taiwan

Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

Taipei City, Taiwan, 11259

National Taiwan Universtiy Hospital; Division of Hematology

Taipei, Taiwan, 100

Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology

Taoyuan, Taiwan, 333

United Kingdom

Aberdeen Royal Infirmary; Haematology - Ward 16

Aberdeen, United Kingdom, AB25 2ZN

Queen Elizabeth Hospital; Centre for Clinical Haematology

Birmingham, United Kingdom, B15 2TH

Royal Bournemouth General Hospital; Haematology

Bournemouth, United Kingdom, BH7 7DW

Bristol Haematology and Oncology Centre

Bristol, United Kingdom, BS2 8ED

Addenbrookes Hospital; Haematology

Cambridge, United Kingdom, CB2 0QQ

Kent & Canterbury Hospital; Clinical Haematology

Canterbury, United Kingdom, CT1 3NG

Velindre NHS Trust; Haematology Department

Cardiff, United Kingdom, CF14 2TL

Castle Hill Hospital; The Queens Centre for Oncology and Haematology

Cottingham, United Kingdom, HU16 5JG

Western General Hospital; Department of Haematology

Edinburgh, United Kingdom, EH4 2XU

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom, G12 0YN

James Paget Hospital; Haematology Department

Great Yarmouth, United Kingdom, NR31 6LA

Princess Alexandra Hospital; Department of Haematology

Harlow, United Kingdom, CM20 1QX

St James Uni Hospital; Icrf Cancer Medicine Research Unit

Leeds, United Kingdom, LS9 7TF

Leicester Royal Infirmary; Dept of Haematology

Leicester, United Kingdom, LE1 5WW

St Bartholomew's Hospital

London, United Kingdom, EC1M 6BQ

King'S College Hospital; Haematology

London, United Kingdom, SE5 9RS

St. George'S Hospital; Haematology

London, United Kingdom, SW17 0QT

Hammersmith Hospital; Haematology

London, United Kingdom, W12 OHS

University College Hospital; Macmillan Cancer Centre

London, United Kingdom, WC1E 6AG

Christie Hospital; Breast Cancer Research Office

Manchester, United Kingdom, M20 4QL

Norfolk & Norwich Hospital; Dept of Haematology

Norwich, United Kingdom, NR4 7UY

Nottingham City Hospital; Dept of Haematology

Nottingham, United Kingdom, NG5 1PB

Churchill Hospital; Oxford Cancer and Haematology Centre

Oxford, United Kingdom, OX3 7LJ

Queen Alexandra Hospital; Haematology and Oncology Centre

Portsmouth, United Kingdom, PO6 3LY

Southampton General Hospital; Medical Oncology

Southampton, United Kingdom, SO16 6YD

Royal Marsden Hospital; Dept of Medical Oncology

Sutton, United Kingdom, SM2 5PT

Singleton Hospital; Pharmacy

Swansea, United Kingdom, SA2 8QA

Great Western;Department of Haematology

Swindon, United Kingdom, SN3 6BB

Royal Cornwall Hospital; Haematology Clinic

Truro, United Kingdom, TR1 3LJ

Sponsors and Collaborators

Hoffmann-La Roche

German Low Grade Lymphoma Study Group

Institute of Cancer Research, United Kingdom

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

Study Protocol  [PDF] February 15, 2020

Statistical Analysis Plan  [PDF] April 12, 2016

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Casulo C, Herold M, Hiddemann W, Iyengar S, Marcus RE, Seymour JF, Launonen A, Knapp A, Nielsen TG, Mir F. Risk Factors for and Outcomes of Follicular Lymphoma Histological Transformation at First Progression in the GALLIUM Study. Clin Lymphoma Myeloma Leuk. 2023 Jan;23(1):40-48. doi: 10.1016/j.clml.2022.09.003. Epub 2022 Oct 4.

Hong X, Song Y, Shi Y, Zhang Q, Guo W, Wu G, Li J, Feng J, Kinkolykh A, Knapp A, Lin T. Efficacy and safety of obinutuzumab for the first-line treatment of follicular lymphoma: a subgroup analysis of Chinese patients enrolled in the phase III GALLIUM study. Chin Med J (Engl). 2021 Sep 16;135(4):433-440. doi: 10.1097/CM9.0000000000001737.

Strefford JC, Nowicka M, Hargreaves CE, Burton C, Davies A, Ganderton R, Hiddemann W, Iriyama C, Klapper W, Latham KV, Martelli M, Mir F, Parker H, Potter KN, Rose-Zerilli MJJ, Sehn LH, Trneny M, Vitolo U, Bolen CR, Klein C, Knapp A, Oestergaard MZ, Cragg MS. Single-nucleotide Fcgamma receptor polymorphisms do not impact obinutuzumab/rituximab outcome in patients with lymphoma. Blood Adv. 2021 Aug 10;5(15):2935-2944. doi: 10.1182/bloodadvances.2020003985.

Davies A, Trask P, Demeter J, Florschutz A, Hanel M, Kinoshita T, Pettengell R, Quach H, Robinson S, Sadullah S, Sancho JM, Udvardy M, Witzens-Harig M, Knapp A, Liu W. Health-related quality of life in the phase III GALLIUM study of obinutuzumab- or rituximab-based chemotherapy in patients with previously untreated advanced follicular lymphoma. Ann Hematol. 2020 Dec;99(12):2837-2846. doi: 10.1007/s00277-020-04021-6. Epub 2020 Apr 20.

Klanova M, Oestergaard MZ, Trneny M, Hiddemann W, Marcus R, Sehn LH, Vitolo U, Bazeos A, Goede V, Zeuner H, Knapp A, Sahin D, Spielewoy N, Bolen CR, Cardona A, Klein C, Venstrom JM, Nielsen T, Fingerle-Rowson G. Prognostic Impact of Natural Killer Cell Count in Follicular Lymphoma and Diffuse Large B-cell Lymphoma Patients Treated with Immunochemotherapy. Clin Cancer Res. 2019 Aug 1;25(15):4634-4643. doi: 10.1158/1078-0432.CCR-18-3270. Epub 2019 May 3.

Kusumoto S, Arcaini L, Hong X, Jin J, Kim WS, Kwong YL, Peters MG, Tanaka Y, Zelenetz AD, Kuriki H, Fingerle-Rowson G, Nielsen T, Ueda E, Piper-Lepoutre H, Sellam G, Tobinai K. Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy. Blood. 2019 Jan 10;133(2):137-146. doi: 10.1182/blood-2018-04-848044. Epub 2018 Oct 19.

Trotman J, Barrington SF, Belada D, Meignan M, MacEwan R, Owen C, Ptacnik V, Rosta A, Fingerle-Rowson GR, Zhu J, Nielsen T, Sahin D, Hiddemann W, Marcus RE, Davies A; PET investigators from the GALLIUM study. Prognostic value of end-of-induction PET response after first-line immunochemotherapy for follicular lymphoma (GALLIUM): secondary analysis of a randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1530-1542. doi: 10.1016/S1470-2045(18)30618-1. Epub 2018 Oct 8. Erratum In: Lancet Oncol. 2019 Apr 29;:

Hiddemann W, Barbui AM, Canales MA, Cannell PK, Collins GP, Durig J, Forstpointner R, Herold M, Hertzberg M, Klanova M, Radford J, Seymour JF, Tobinai K, Trotman J, Burciu A, Fingerle-Rowson G, Wolbers M, Nielsen T, Marcus RE. Immunochemotherapy With Obinutuzumab or Rituximab for Previously Untreated Follicular Lymphoma in the GALLIUM Study: Influence of Chemotherapy on Efficacy and Safety. J Clin Oncol. 2018 Aug 10;36(23):2395-2404. doi: 10.1200/JCO.2017.76.8960. Epub 2018 Jun 1.

Marcus R, Davies A, Ando K, Klapper W, Opat S, Owen C, Phillips E, Sangha R, Schlag R, Seymour JF, Townsend W, Trneny M, Wenger M, Fingerle-Rowson G, Rufibach K, Moore T, Herold M, Hiddemann W. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. N Engl J Med. 2017 Oct 5;377(14):1331-1344. doi: 10.1056/NEJMoa1614598.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01332968
• Other Study ID Numbers: BO21223; 2010-024132-41 ( EudraCT Number )
• First Posted: April 11, 2011
• Results First Posted: June 7, 2017
• Last Update Posted: August 11, 2022
• Last Verified: August 2022

Additional relevant MeSH terms:

Lymphoma; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Prednisone; Cyclophosphamide; Bendamustine Hydrochloride; Rituximab; Doxorubicin; Vincristine; Obinutuzumab; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Myeloablative Agonists; Antineoplastic Agents, Immunological; Antibiotics, Antineoplastic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Anti-Inflammatory Agents