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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
German Low Grade Lymphoma Study Group
Institute of Cancer Research, United Kingdom
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01332968
First received: April 8, 2011
Last updated: September 8, 2017
Last verified: September 2017
  Purpose
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 Intervention Phase
Non-Hodgkin's Lymphoma Drug: Obinutuzumab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Drug: Bendamustine Drug: Rituximab Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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:
  • Progression-Free Survival in the Overall Study Population, Investigator-Assessed [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 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.

  • Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 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.

  • Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC) [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Overall Survival (Follicular Lymphoma Population) [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 months ]
    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.

  • Overall Survival (Overall Study Population) [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 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.

  • Event-Free Survival (Follicular Lymphoma Population) [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 months) ]
    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.

  • Event-Free Survival (Overall Study Population) [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 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.

  • Disease-Free Survival (Follicular Lymphoma Population) [ Time Frame: From first occurrence of documented CR to data cut-off (up to approximately 4 years and 7 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.

  • Disease-Free Survival (Overall Study Population) [ Time Frame: From first occurrence of documented CR to data cut-off (up to approximately 4 years and 7 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.

  • 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 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.

  • 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.

  • Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population) [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 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.

  • Time to Next Anti-Lymphoma Treatment (Overall Study Population) [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 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.

  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 months) ]
    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.

  • 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 4 years and 7 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.

  • 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 4 years and 7 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.

  • 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 4 years and 7 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.

  • 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 4 years and 7 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.

  • 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 4 years and 7 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.

  • 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 4 years and 7 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.

  • 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 4 years and 7 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.


Enrollment: 1401
Actual Study Start Date: August 1, 2011
Estimated Study Completion Date: September 1, 2021
Primary Completion Date: February 1, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332968

  Hide Study Locations
Locations
United States, Arkansas
Highlands Oncology Group
Rogers, Arkansas, United States, 72758
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 (Loofstraat)
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. Léon-Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C8X3
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
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, China, 100021
Peking University First Hospital
Beijing, China, 100034
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
Fujian, China, 350001
Fujian Cancer Hospital
Fuzhou, China, 350014
Sun Yet-sen University Cancer Center
Guangzhou, China, 510060
Harbin Medical University Cancer Hospital
Harbin, China, 150081
Jiangsu Cancer Hospital
Nanjing, China, 210009
Jiangsu Province Hospital
Nanjing, China, 210036
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200025
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
First Affiliated Hospital of Soochow University
Suzhou, China, 215006
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
Wuhan, China, 430022
Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
Wuhan, China, 430023
Czechia
Fakultni nemocnice Brno; Interni hematoonkologicka 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, 00029
Tampere University Hospital; Dept of Oncology
Tampere, Finland, 33520
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
Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie
Amberg, Germany, 92224
Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch
Berlin, Germany, 14195
DIAKO Ev. Diakonie-Krankenhaus Bremen GmbH; Med. Klinik II; Hämatologie und internistische Onkologie
Bremen, Germany, 28239
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
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; Haematologie/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 und Stammzelltr.
Freiburg, Germany, 79106
Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik
Greifswald, Germany, 17475
Universität Georg-August-Universität Göttingen; Abteilung Hämatologie und 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
Onkologische Schwerpunktpraxis Hof; Dres. Hanns-Detlev; Harich und Christian Kasper
Hof, Germany, 95028
Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I
Homburg/Saar, Germany, 66421
Klinikum Idar-Oberstein, Medizinische Klinik I
Idar-Oberstein, Germany, 55743
Universitätsklinikum Jena; Klinik für Innere Medizin II
Jena, Germany, 07747
UKSH Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie
Kiel, Germany, 24105
Institut für Versorgungsforschung in der Onkologie GbR
Koblenz, Germany, 56068
Klinik der Uni zu Köln; Klinik für Innere Medizin
Köln, Germany, 50924
Tagesklinik Landshut; Hämatologie/Onkologie
Landshut, Germany, 84028
Caritas Krankenhaus; Haematologie/Intern. 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
Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie
Magdeburg, Germany, 39130
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
Klinikum der Universitaet Muenchen; Campus Großhadern; Medizinische Klinik III und Poliklinik
Muenchen, Germany, 81377
Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin
Mutlangen, Germany, 73557
St. Frankziskus Krankenhaus Mönchengladbach; Klinik für Hämatologie Onkologie und Gastroenterologie
Mönchengladbach, Germany, 41063
Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)
München, Germany, 81675
Westfälische Wilhelms-Universität Münster, Medizinische Klinik und Poliklinik A
Münster, Germany, 48149
Praxis Dr.med. Peter Schmidt
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 Haematologie & Onkologie
Saarbruecken, Germany, 66113
MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
Stade, Germany, 21680
Diakonie-Klinikum Stuttgart; Innere Medizin II
Stuttgart, Germany, 70176
Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie
Trier, Germany, 54292
Eberhard-Karls-Universität Tübingen; Medizinische Klinik I
Tübingen, Germany, 72076
Universtitätsklinikum Ulm; Klinik für Innere Medizin III
Ulm, Germany, 89081
HSK Dr.-Horst-Schmidt-Kliniken; Innere Medizin I Kardiologie; Angiologie und Intensivmedizin
Wiesbaden, Germany, 65199
Onkologische Schwerpunktpraxis Dres. Rudolf Schlag und Björn 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
Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology
Kaposvar, Hungary, 7400
University of Szeged, II Dept of Internal Medicine
Szeged, Hungary, 6720
Israel
Rambam Medical Center; Heamatology & Bone Marrow Transplantation
Haifa, Israel, 3109601
Hadassah Ein Karem Hospital; Haematology
Jerusalem, Israel, 9112001
Beilinson Medical Center; Haematology
Petach Tikva, Israel, 49100
Chaim Sheba Medical Center; Hematology BMT & CBB
Ramat Gan, Israel, 52662
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
Nagoya Daini Red Cross 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. N. N. Blokhin" of Ministry of Health of the Russian Fed
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
Södersjukhuset, Medicinkliniken/Sektionen för Hematologi
Stockholm, Sweden, 118 83
Taiwan
National Taiwan Universtiy Hospital; Division of Hematology
Taipei, Taiwan, 100
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
Taipei, Taiwan, 112
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, EC1A 7BE
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
Royal Marsden Hospital; Academic Dept of Haematology
Sutton, United Kingdom, SW3 6JJ
Singleton Hospital; Oncology
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
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01332968     History of Changes
Other Study ID Numbers: BO21223
2010-024132-41 ( EudraCT Number )
Study First Received: April 8, 2011
Results First Received: February 3, 2017
Last Updated: September 8, 2017

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

ClinicalTrials.gov processed this record on September 19, 2017