A Phase 1b, Multicenter, Open-Label, Dose Escalation Study of SAR245409 to Evaluate the Safety, Tolerability and Clinical Activity of SAR245409 in Combination With Rituximab or Bendamustine Plus Rituximab in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia

Inclusion Criteria

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.
pamtoprazole) 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.