A Study of RO5072759 (GA101) in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)
Overview[ - collapse ][ - ]
Purpose | This open-label, multicenter study will evaluate the efficacy and safety of RO5072759 (GA101) in combination with CHOP chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients will receive 8 cycles of RO5072759 (1000 mg intravenously on Day 1 of each 21-day cycle, during Cycle 1 RO5072759 will also be infused on Days 8 and 15) in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemotherapy during cycles 1 to 6. A substudy will investigate the drug-drug interaction of RO5072759 (GA101) with CHOP chemotherapy agents. For the substudy, an additional cohort of 15 patients will be enrolled at a subset of investigational sites. |
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Condition | Lymphoma, B-Cell |
Intervention | Drug: RO5072759 Drug: cyclophosphamide Drug: doxorubicin Drug: vincristine Drug: prednisone |
Phase | Phase 2 |
Sponsor | Genentech |
Responsible Party | Genentech |
ClinicalTrials.gov Identifier | NCT01414855 |
First Received | August 10, 2011 |
Last Updated | April 7, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | August 10, 2011 |
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Last Updated Date | April 7, 2014 |
Start Date | August 2011 |
Estimated Primary Completion Date | February 2017 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | A Study of RO5072759 (GA101) in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER) |
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Official Title | A Phase II, Open-Label, Multicenter Study of Efficacy, Safety, and Biomarkers in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma Treated With GA101 (RO5072759) in Combination With CHOP Chemotherapy |
Brief Summary | This open-label, multicenter study will evaluate the efficacy and safety of RO5072759 (GA101) in combination with CHOP chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients will receive 8 cycles of RO5072759 (1000 mg intravenously on Day 1 of each 21-day cycle, during Cycle 1 RO5072759 will also be infused on Days 8 and 15) in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemotherapy during cycles 1 to 6. A substudy will investigate the drug-drug interaction of RO5072759 (GA101) with CHOP chemotherapy agents. For the substudy, an additional cohort of 15 patients will be enrolled at a subset of investigational sites. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Lymphoma, B-Cell |
Intervention | Drug: RO5072759 1000 mg intravenously on Day 1 of each 21-day cycle, 8 cycles; during Cycle 1 administration also on Days 8 and 15 Drug: cyclophosphamide 750 mg/m2 iv, Day 1 of each 21-day cycle, 6 cycles Drug: doxorubicin 50 mg/m2 iv, Day 1 of each 21-cycle, 6 cycles Drug: vincristine 1.4 mg/m2 iv, Day 1 of each 21-day cycle, 6 cycles Drug: prednisone 100 mg/day, Days 1 through 5 of each 21-day cycle, 6 cycles |
Study Arm (s) | Experimental: Single Arm |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
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Estimated Enrollment | 100 |
Estimated Completion Date | February 2017 |
Estimated Primary Completion Date | January 2017 |
Eligibility Criteria | Inclusion Criteria: - Adult patients, >/= 18 years of age - Previously untreated CD20-positive diffuse large B-cell lymphoma - Ann Arbour Stage III/IV and bulky II (mass >10 cm) - At least one bi-dimensionally measurable lesion defined as >1.5 cm in its largest dimension by CT scan - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 - Left ventricular ejection fraction >/= 50% - Adequate hematologic function Exclusion Criteria: - Transformed lymphoma (follicular IIIB) if previously treated with chemotherapy or immunotherapy - Prior therapy for diffuse large B-cell lymphoma except for nodal biopsy or local irradiation - CNS lymphoma, primary mediastinal large cell lymphoma, primary cutaneous lymphoma, primary effusion lymphoma - Patients who received cytotoxic drugs or rituximab as part of their treatment for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody - Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1 - Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines - History of severe allergic or anaphylactic reactions to monoclonal antibody therapy - History of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix, or malignancy treated with or without curative intent and in remission without treatment for >/=2 years prior to enrolment - Positive for hepatitis B, hepatitis C, HIV or HTLV-1 infection - Pregnant or lactating women |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01414855 |
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Other Study ID Numbers | GAO4915g |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Genentech |
Study Sponsor | Genentech |
Collaborators | Not Provided |
Investigators | Study Director: Clinical Trials Genentech |
Verification Date | April 2014 |
Locations[ + expand ][ + ]
United States, Alabama | Birmingham, Alabama, United States, 35291-3300 |
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United States, California | Encinitas, California, United States, 92024 |
United States, Colorado | Aurora, Colorado, United States, 80045 |
United States, Colorado | Denver, Colorado, United States, 80218 |
United States, Connecticut | Norwalk, Connecticut, United States, 06856 |
United States, Florida | Fort Myers, Florida, United States, 33916 |
United States, Florida | St Petersburg, Florida, United States, 33719 |
United States, Georgia | Marietta, Georgia, United States, 30060 |
United States, Idaho | Coeur D'alene, Idaho, United States, 83814 |
United States, Illinois | Chicago, Illinois, United States, 60611 |
United States, Illinois | Peoria, Illinois, United States, 61615-7828 |
United States, Iowa | Ames, Iowa, United States, 50010 |
United States, Kentucky | Louisville, Kentucky, United States, 40245 |
United States, Massachusetts | Worcester, Massachusetts, United States, 01655 |
United States, Michigan | Ann Arbor, Michigan, United States, 48109-0934 |
United States, Montana | Missoula, Montana, United States, 59802 |
United States, Nevada | Las Vegas, Nevada, United States, 89148 |
United States, New Jersey | Basking Ridge, New Jersey, United States, 07920 |
United States, New Jersey | Hackensack, New Jersey, United States, 07601 |
United States, New Mexico | Farmington, New Mexico, United States, 87401 |
United States, New York | Commack, New York, United States, 11725 |
United States, New York | New York, New York, United States, 10065 |
United States, New York | Rockville Centre, New York, United States, 11570 |
United States, New York | Sleepy Hollow, New York, United States, 10591 |
United States, North Carolina | High Point, North Carolina, United States, 27262 |
United States, Oregon | Springfield, Oregon, United States, 97477 |
United States, South Carolina | Charleston, South Carolina, United States, 29524 |
United States, Tennessee | Nashville, Tennessee, United States, 37203 |
United States, Texas | Fort Worth, Texas, United States, 76177 |
United States, Texas | Houston, Texas, United States, 77030 |
United States, Texas | Tyler, Texas, United States, 75702 |
United States, Virginia | Roanoke, Virginia, United States, 24014 |
United States, Washington | Spokane, Washington, United States, 99208 |
United States, Washington | Vancouver, Washington, United States, 98684 |
United States, Washington | Yakima, Washington, United States, 98902 |
United States, Wisconsin | Green Bay, Wisconsin, United States, 54311 |