Chronic Lymphocytic Leukemia Clinical Trial
A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia
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
Full 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.
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.
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There are 30 Locations for this study
Los Angeles California, 90033, United States
Fort Meyers Florida, 33919, United States
Augusta Georgia, 30912, United States
Maywood Illinois, 60153, United States
Kansas City Kansas, 66160, United States
Lexington Kentucky, 40536, United States
Paducah Kentucky, 42002, United States
Boston Massachusetts, 02115, United States
St Louis Missouri, 63110, United States
Canton Ohio, 44718, United States
Philadelphia Pennsylvania, 19111, United States
Morgantown West Virginia, 26506, United States
Clayton , 3168, Australia
Hobart , 7001, Australia
Kingswood , 2747, Australia
Perth , 6000, Australia
Bruxelles , 1000, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Montpellier , 34295, France
Pierre Benite Cedex , 69495, France
Rennes , 35033, France
Rouen Cedex , 76038, France
Villejuif Cedex , 94805, France
Frankfurt Am Main , 60590, Germany
Jena , 07747, Germany
Ulm , 89081, Germany
Amsterdam , 1105 , Netherlands
Groningen , 9713 , Netherlands
Rotterdam , 3075 , Netherlands
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