EUCTR2011-001616-57-DE进行中（未招募）不适用
A Phase 2 study of SAR245409 in patients with relapsed or refractory mantle cell lymphoma, follicular lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma or diffuse large B-cell lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- •Tissue from an archived or fresh tumor sample
- •A peripheral blood buffy coat sample is required for CLL/SLL.
- •Patient has mantle cell lymphoma (MCL), follicular lymphoma (FL), or chronic lymphocytic leukemia (CLL)/SLL or diffuse large B cell lymphoma (DLBCL)
- •Patient > or = 18 years old
- •ECOG performance status < or = 2
- •Patients with DLBCL will have ECOG < or =1
- •Adequate white blood cells and hemoglobin
- •Good kidney and liver function
- •Fasting glucose < 160 mg/dL
- •No other malignancy
- •Use of adequate birth control
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •- Treatment with cytotoxic chemotherapy, biologic agents, investigational therapies within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks of study enrollment
- •- Treatment with a small-molecule kinase inhibitor within 2 weeks, or 5 half lives of the drug or its active metabolites (whichever is longer) of study enrollment
- •- Prior treatment with a PI3K, mTOR, or Akt inhibitor. Prior treatment of MCL with temsirolimus is permitted in patients enrolled from countries where it is licensed for this indication.
- •- Radiation therapy within 2 weeks of enrollment
- •- Autologous stem cell transplantation within 16 weeks of enrollment
- •- Prior allogeneic transplantation except for patients with R/R DLBCL who meet inclusion criteria
- •- Central nervous system or leptomeningeal involvement.Patients with DLBCL may have active CNS or leptomeningeal involvement.
- •- Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (anti-HCV) serology
- •- Primary CNS lymphoma
- •- Primary mediastinal B-cell lymphoma
研究者
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