Lead Sponsor

Sanofi

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•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
•Patient \> or = 18 years old
•Eastern Cooperative Oncology Group (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
•Central nervous system (CNS) 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-lymphoma
•The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

•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

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