EUCTR2012-002208-41-ES进行中（未招募）1 期
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
ovartis Farmacéutica S.A.0 个研究点目标入组 66 人开始时间: 2013年1月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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:
- •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
- •1.1. 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
研究者
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