A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)
Completed · Phase 2
Conditions studied: Lymphoma, B-Cell
In brief
This open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab \[RO5072759 (GA101)\] in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients will receive 8 cycles of obinutuzumab (1000 mg intravenously on Day 1 of each 21-day cycle, during Cycle 1 obinutuzumab will also be infused on Days 8 and 15) in combination with CHOP chemotherapy on Day 1 of cycles 1 to 6. A substudy will investigate the drug-drug interaction of obinutuzumab with CHOP chemotherapy agents. For the substudy, an additional cohort of approximately 15 patients are planned to be enrolled at a subset of investigational sites.
Key facts
- Study ID
- NCT01414855
- Run by
- Genentech, Inc.
- People needed
- 100
- Starts
- 2011-08-31
- Expected to finish
- 2016-12-23
- Last updated by the study team
- 2018-04-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients, ≥18 years of age
- Previously untreated cluster of differentiation antigen 20 (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
You may not qualify if…
- 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
- Central nervous system (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, human immunodeficiency virus (HIV) or human T-cell leukemia virus (HTLV-1) infection
- Pregnant or lactating women
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- cCare — Encinitas, California, United States
- University of Colorado Cancer Center Department of Hematology — Aurora, Colorado, United States
- Rocky Mountain Cancer Ctr - Denver (Williams) — Denver, Colorado, United States
- Norwalk Hospital — Norwalk, Connecticut, United States
- Florida Cancer Specialists; Department of Oncology — Fort Myers, Florida, United States
- Florida Cancer Specialists; Saint Petersburg — St. Petersburg, Florida, United States
- Northwest Georgia Oncology Centers PC - Marietta — Marietta, Georgia, United States
- Kootenai Medical Center — Coeur d'Alene, Idaho, United States
- Northwestern University; Robert H. Lurie Comp Can Ctr — Chicago, Illinois, United States
- Onc Hem Assoc of Central IL — Peoria, Illinois, United States
- McFarland Clinic — Ames, Iowa, United States
- Jewish Cancer Care — Louisville, Kentucky, United States
- University of Massachusetts Medical School — Worcester, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- MT Cancer Inst Fndtn; MT Can Spec — Missoula, Montana, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- MSKCC at Basking Ridge — Basking Ridge, New Jersey, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- San Juan Oncology Associates — Farmington, New Mexico, United States
- Memorial Sloan-Kettering; Cancer Center — Commack, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- MSKCC at Mercy Med Ctr — Rockville Centre, New York, United States
- MSKCC at Sleepy Hollow — Sleepy Hollow, New York, United States
- Emerywood Hematology and Onc — High Point, North Carolina, United States
Full record on ClinicalTrials.gov
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