Study Combining SAR245409 With Rituximab or Bendamustine Plus Rituximab in Patients With Indolent Lymphoma, Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia

Inclusion criteria:

A confirmed diagnosis of indolent non-Hodgkin lymphoma, mantle cell lymphoma or chronic lymphocytic leukemia
Evaluable disease or measurable disease
Transfusion independent
Able to take oral medication
Male and Female subjects > 18 years
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Women of childbearing potential using adequate contraception

Exclusion criteria:

Prior therapy with a PI3K, mTOR or dual PI3K/mTOR inhibitor resulting in adverse events necessitating treatment discontinuation
Eligible for a hematopoietic stem cell transplant (HSCT)
The subject has received investigational or non-investigational cytotoxic chemotherapy (i.e., cyclophosphamide), small molecule cancer therapy (i.e., imatinib), biologic cancer therapies other than rituximab (i.e., alemtuzumab, cytokines, vaccines or other monoclonal antibodies) hormonal therapy, radio- or immuno- conjugates (e.g. ibritumomab tiuxetan, tositumomab) or immunosuppressants to treat malignancy within 4 weeks prior to Cycle 1, Day 1
Radiation therapy within 2 weeks prior to Cycle 1, Day 1
Autologous Hematopoietic Stem Cell Transplant (HSCT) within the past 16 weeks
Prior allogeneic HSCT
Active central nervous system (CNS) metastases or leptomeningeal involvement
Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C Antibody (anti-HCV)
Hereditary or acquired immunodeficiency syndrome or human immunodeficiency virus (HIV) infection
Active peptic ulcer disease requiring treatment with proton pump inhibitors (e.g. pantoprazole) or Type 2 histamine antagonists (e.g. cimetidine)
Diagnosis or treatment for another malignancy within 3 years of enrollment with the exception of complete resection of basal cell or squamous cell carcinoma of the skin, an in situ malignancy or low-risk prostate cancer after curative therapy
Inadequate bone marrow function
Abnormal liver function
Abnormal renal function
Abnormal coagulation

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.