EUCTR2010-024194-39-GB进行中（未招募）1 期
A PHASE III, MULTICENTER, OPEN-LABEL, RANDOMIZED TRIAL COMPARING THE EFFICACY OF GA101 (RO5072759) IN COMBINATION WITH CHOP (G-CHOP) VERSUS RITUXIMAB AND CHOP (R-CHOP) IN PREVIOUSLY UNTREATED PATIENTS WITH CD20 POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) - GOYA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,414
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Adult patients, >/= 18 years of age
- •Previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL)
- •At least 1 bi-dimensionally measurable lesion (>1.5 cm in is largest dimension on the CT scan)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- •Adequate hematological function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 700
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 700
排除标准
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products or any component of CHOP or GA101
- •Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
- •Diagnosis of transformed lymphoma (follicular IIIB) if previously treated with radiotherapy, chemotherapy, or immunotherapy
- •Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation
- •Prior treatment with cytotoxic drugs or rituximab for another condition (e.g., rheumatoid arthritis) or prior use of an anti-CD20 antibody
- •Prior use of any monoclonal antibody within 3 months of the start of Cycle 1
- •Ongoing corticosteroid use of > 30 mg/day of prednisone or equivalent, for purposes other then lymphoma symptom control
- •Primary CNS lymphoma and secondary CNS invilvement by lymphoma, MCL, or histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, plasmablastic lymphoma, and primary cutaneous DLBCL
- •Patients with a history of confirmed PML
研究者
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