A Phase 2 study of SAR245409 in patients with relapsed or refractory mantle cell lymphoma, follicular lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma - ARD12130

Sanofi-aventis0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•* 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
•* Patient ><= 18 years old
•* ECOG performance status < <= 2
•* Adequate white blood cells and hemoglobin
•* Good kidney and liver function
•* Fasting glucose < 160 mg/dL
•* No other malignancy
•* Use of adequate birth control

•- 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
•- Central nervous system or leptomeningeal involvement
•- Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (anti-HCV) serology

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