Status:
COMPLETED
A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)
Lead Sponsor:
Genentech, Inc.
Conditions:
Lymphoma, B-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab \[RO5072759 (GA101)\] in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemoth...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 31 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01414855
Start Date
August 31 2011
End Date
December 23 2016
Last Update
April 25 2018
Active Locations (38)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
2
cCare
Encinitas, California, United States, 92024
3
University of Colorado Cancer Center Department of Hematology
Aurora, Colorado, United States, 80045
4
Rocky Mountain Cancer Ctr - Denver (Williams)
Denver, Colorado, United States, 80218