A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)

Launched by GENENTECH, INC. · Aug 10, 2011

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 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
• • 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