A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia

Study Overview
=================
Brief Summary
-----------------
Primary Objective: - To evaluate the efficacy of SAR245409 as determined by the objective response rate (ORR) in patients with 1 of following relapsed or refractory lymphoma or leukemia subtypes: mantle cell lymphoma (MCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), or diffuse large B cell lymphoma (DLBCL) Secondary Objectives: To assess duration of response, progression free survival (PFS), and proportion of patients with PFS at 6 months (24 weeks) in patients with either MCL, FL, CLL/SLL or DLBCL treated with SAR245409 To evaluate the safety and tolerability of SAR245409 in patients with MCL, FL, CLL/SLL or DLBCL To further characterize the plasma pharmacokinetics (PK) of SAR245409 in patients with MCL, FL, CLL/SLL or DLBCL

Detailed Description
-----------------
There is a 21 day screening period followed by 28 day cycles. Patients will continue to receive SAR245409 as long as there is clinical benefit or until a study withdrawal criterion is met. The last posttreatment visit will be 30 days after the last dose or until IMP-related toxicities have resolved or are deemed irreversible, whichever is later.

Official Title
-----------------
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

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: SAR245409


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 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 Exclusion criteria: 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 (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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mantle cell<br>50 mg twice daily: no eating for 2 hours prior and 1 hour after dose | Drug: SAR245409<br>* Pharmaceutical form:capsule Route of administration: oral<br>|
| Experimental: follicular lymphoma<br>50 mg twice daily: no eating for 2 hours prior and 1 hour after dose | Drug: SAR245409<br>* Pharmaceutical form:capsule Route of administration: oral<br>|
| Experimental: CLL/SLL<br>50 mg twice daily:no eating for 2 hours prior and 1 hour after dose | Drug: SAR245409<br>* Pharmaceutical form:capsule Route of administration: oral<br>|
| Experimental: Diffuse large B cell lymphoma<br>50 mg twice daily:no eating for 2 hours prior and 1 hour after dose | Drug: SAR245409<br>* Pharmaceutical form:capsule Route of administration: oral<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) as defined as the proportion of patients who experience complete response/remission (CR) or partial response/remission (PR) |  | 2 months to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) at 6 months |  | 6 months to 2 years |