EUCTR2011-002565-38-IT进行中（未招募）不适用
A Phase 2 Randomized Open-label Study of MEDI-551 in AdultsWith Relapsed or Refractory DLBC
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 170
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
- 性别
- All
入选标准
- •Histologically confirmed aggressive B-cell DLBCL, including FL
- •transforming to DLBCL & Grade III FL
- •Relapsed from or refractory to at least one treatment containing
- •rituximab or another anti-CD20 based immunotherapy combined with
- •anthracycline- or anthracenedione-based chemotherapy
- •Eligible for ASCT
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0,
- •Life expectancy of = 12 weeks
- •Adequate hematological function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Any chemotherapy, radiotherapy, immunotherapy, biologic,
- •investigational or hormonal therapy for treatment of lymphoma within
- •28 days prior to treatment
- •Previous cancer therapy for DLBCL other than anthracycline- or
- •anthracenedione based chemoimmunotherapy, monotherapy rituximab
- •prior to first line therapy and/or as a maintenance therapy, or limited
- •field radiotherapy
- •Prior autologous or allogeneic SCT
- •New York Heart Association = Class II congestive heart failure;
- •Clinically significant abnormality on ECG
- •History of other invasive malignancy within 5 years except for
- •localized/in situ, carcinomas such as cervical carcinoma in situ.
- •Evidence of active infection
- •Documented current central nervous system involvement by leukemia
- •or lymphoma
研究者
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