EUCTR2012-002208-41-IT进行中（未招募）不适用
An open-label phase II study of BKM120 in patients with relapsed and refractory diffuse large B-cell lymphoma, mantle cell lymphoma and follicular lymphoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 66
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
- •1.Patient has a histologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma, or diffuse large B cell lymphoma. 2. Patient has relapsed or refractory disease and received at least one prior therapy. 3. Patient with diffuse large B cell lymphoma has received or is ineligible for autologous or allogeneic stem cell transplant. 4. Patient has at least one measurable nodal lesion (=2 cm) according to Cheson criteria (Cheson 2007). In case where the patient has no measurable nodal lesions = 2 cm in the long axis at baseline, then the patient must have at least one measurable extra-nodal lesion. 5. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status = 2. 6. Patient has adequate bone marrow and organ 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 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 33
排除标准
- •1. Patient has received previous treatment with PI3K. 2. Patient has evidence of graft versus host disease (GVHD). 3. Patient has active or history of central nervous system (CNS) disease. 4. Patient has a concurrent malignancy or has a malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer). 5. Patient has a score = 12 on the PHQ-9 questionnaire. 6. Patient has a GAD-7 mood scale score = 15. 7. Pregnant or nursing women and who does not use highly effective contraception methods to avoid becoming pregnant or conciving offspring. Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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