PER-004-13未知未知
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)
F. Hoffmann La Roche Ltd / Genentech Inc,0 个研究点目标入组 8 人开始时间: 2013年10月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 85（—）
入选标准
- •* Patients in an IPI disease risk group that is one of the following: high, high-intermediate, or low-intermediate. Patients in the low-risk group are eligible but must have an IPI score of 1,
- •irrespective of bulky disease or IPI score of 0 with bulky disease, defined as one lesion ≥ 7.5 cm.
- •At least one bi-dimensionally measurable lesion defined as > 1.5 cm in its largest dimension on CT scan,
- •Ability and willingness to comply with the study protocol procedures,
- •Age ≥ 18 years,
- •ECOG performance status of 0, 1, or 2
- •LVEF ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac
- •echocardiogram,
- •Adequate hematologic function.
排除标准
- •* Corticosteroid use > 30 mg/day of prednisone or equivalent, for purposesother than lymphoma symptom control.
- •* Primary CNS lymphoma and secondary CNS involvement by lymphoma, MCL, or histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, plasmablastic lymphoma, and primary
- •cutaneous DLBCL.
- •* Vaccination with live vaccines within 28 days prior to randomization.
- •* Any investigational therapy within 28 days prior to the start of Cycle 1.
- •* History of other malignancy that could affect compliance with the protocol or interpretation of results.
- •* Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease.
- •* Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis.
- •* abnormal laboratory values.
研究者
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