A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With MabThera/Rituxan (Rituximab) Plus Chemotherapy Followed by GA101 or MabThera/Rituxan Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM) | Not Recruiting
A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With MabThera/Rituxan (Rituximab) Plus Chemotherapy Followed by GA101 or MabThera/Rituxan Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)
Health Conditions
  • Non-Hodgkin's Lymphoma
Not Recruiting
Recruitment Status
NCT01332968
Primary Trial ID Number
Summary
This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to MabThera/Rituxan (rituximab) with chemotherapy followed by obinutuzumab or MabThera/Rituxan maintenance in patients with untreated advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, patients achieving response (CR or PR) will go on to a maintenance period thereby continuing on their 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 patients will be followed for 5 years until progression. After progression, patients will be followed for new anti-lymphoma therapy and overall survival until the end of the study.
Primary Outcome Measures
  • Progression-free survival in patients with follicular lymphoma, investigator-assessed according to the Revised Response Criteria for Malignant Lymphoma; up to approximately 7.5 years
Secondary Outcome Measures
  • Progression-free survival in the overall study population, investigator-assessed; up to approximately 7.5 years; Progression-free survival, Independent Review Committee - assessed; up to approximately 7.5 years; Response (overall response and complete response), investigator-assessed; 168 days; Response (overall response and complete response), Independent Review Committee - assessed; 168 days; Overall survival; up to approximately 10.7 years; Event-free survival; up to approximately 7.5 years; Disease-free survival; up to approximately 7.5 years; Duration of response; up to approximately 7.5 years; Time to next anti-lymphoma treatment; up to approximately 10.7 years; Safety: Incidence of adverse events; up to approximately 10.7 years; Patient-reported outcomes (Functional Assessment of Cancer Therapy for Lymphoma scale, EuroQol EQ-5D questionnaire); up to approximately 7.5 years; Medical resource utilization (hospitalizations, subsequent drug therapies, medical and surgical procedures); up to approximately 7.5 years
Research Question
  • This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to MabThera/Rituxan (rituximab) with chemotherapy followed by obinutuzumab or MabThera/Rituxan maintenance in patients with untreated advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, patients achieving response (CR or PR) will go on to a maintenance period thereby continuing on their 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 patients will be followed for 5 years until progression. After progression, patients will be followed for new anti-lymphoma therapy and overall survival until the end of the study.
Design Type
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Ethics Approval
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Publications
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Countries of Recruitment
United States; Australia; Belgium; Canada; China; Czech Republic; Finland; France; Germany; Hungary; Israel; Italy; Japan; Russian Federation; Spain; Sweden; Taiwan; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
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Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Adult patients, >/= 18 years of age
  • - 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 tumour diameter >/= 7
  • cm), requiring treatment
  • - For patients with follicular lymphoma: requirement for treatment according to GELF
  • criteria
  • - For patients with symptomatic 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 (>2 cm in its largest dimension by CT
  • scan or MRI)
  • - Eastern Cooperative Oncology Group (ECOG) performance status 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 patients with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma
  • with chemotherapy, immunotherapy, or radiotherapy
  • - For patients 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 patients who will be receiving CHOP: LVEF <50% by MUGA scan or echocardiogram
  • - History of prior malignancy with the exception of curatively treated basal or
  • squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
  • - 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, AST or ALT, total bilirubin, INR, PTT or aPPT, unless these abnormalities
  • are due to underlying lymphoma
  • - Positive as per protocol definition for HIV, 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
Participant Exclusion Criteria
  • Inclusion Criteria:
  • - Adult patients, >/= 18 years of age
  • - 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 tumour diameter >/= 7
  • cm), requiring treatment
  • - For patients with follicular lymphoma: requirement for treatment according to GELF
  • criteria
  • - For patients with symptomatic 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 (>2 cm in its largest dimension by CT
  • scan or MRI)
  • - Eastern Cooperative Oncology Group (ECOG) performance status 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 patients with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma
  • with chemotherapy, immunotherapy, or radiotherapy
  • - For patients 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 patients who will be receiving CHOP: LVEF <50% by MUGA scan or echocardiogram
  • - History of prior malignancy with the exception of curatively treated basal or
  • squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
  • - 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, AST or ALT, total bilirubin, INR, PTT or aPPT, unless these abnormalities
  • are due to underlying lymphoma
  • - Positive as per protocol definition for HIV, 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
Interventions
Drug; RO5072759; 1000 mg iv on Days 1, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2-8 (21-day cycles) or Cycles 2-6 (28-day cycles); followed by 1000 mg iv every 2 months in responders until disease progression, for up to 2 years; [B]; Drug; chemotherapy; CHOP (6 cycles of 21 days), CVP (8 cycles of 21 days), Bendamustine (6 cycles of 28 days). Patients with follicular lymphoma are receiving either CHOP, CVP or Bendamustine as background chemotherapy as selected by each participating site at study start. Background chemotherapy for patients with non-follicular lymphoma will be chosen by the site individually for each patient.; [A, B]; Drug; rituximab [MabThera/Rituxan]; 375 mg/m2 iv on Day 1 of Cycles 1-8 (21-day cycles) or Cycles 1-6 (28-day cycles); followed by 375 mg/m2 iv every 2 months in responders until disease progression, for up to 2 years; [A]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific Title
A Multicentre, Phase III, Open Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) + Chemotherapy Compared to Rituximab + Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders.
Secondary Trial Identifying Number
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Website
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Study Funded By
Hoffmann-La Roche
Funder Type
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Study Sponsored By
Hoffmann-La Roche
Study Also Sponsored By
German Low Grade Lymphoma Study Group; Institute of Cancer Research, United Kingdom
Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

08 Apr 2011

Last Updated

01 Jul 2015

Date Record Refreshed on UKCTG

31 Jul 2015