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

View Full Description

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.

View Eligibility 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.

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

167

Study ID:

NCT01403636

Recruitment Status:

Completed

Sponsor:

Sanofi

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There are 30 Locations for this study

See Locations Near You

Investigational Site Number 840012
Los Angeles California, 90033, United States
Investigational Site Number 840104
Fort Meyers Florida, 33919, United States
Investigational Site Number 840006
Augusta Georgia, 30912, United States
Investigational Site Number 840011
Maywood Illinois, 60153, United States
Investigational Site Number 840010
Kansas City Kansas, 66160, United States
Investigational Site Number 840013
Lexington Kentucky, 40536, United States
Investigational Site Number 840007
Paducah Kentucky, 42002, United States
Investigational Site Number 840004
Boston Massachusetts, 02115, United States
Investigational Site Number 840015
St Louis Missouri, 63110, United States
Investigational Site Number 840014
Canton Ohio, 44718, United States
Investigational Site Number 840001
Philadelphia Pennsylvania, 19111, United States
Investigational Site Number 840002
Morgantown West Virginia, 26506, United States
Investigational Site Number 036002
Clayton , 3168, Australia
Investigational Site Number 036001
Hobart , 7001, Australia
Investigational Site Number 036005
Kingswood , 2747, Australia
Investigational Site Number 036003
Perth , 6000, Australia
Investigational Site Number 056003
Bruxelles , 1000, Belgium
Investigational Site Number 056002
Gent , 9000, Belgium
Investigational Site Number 056001
Leuven , 3000, Belgium
Investigational Site Number 250002
Montpellier , 34295, France
Investigational Site Number 250001
Pierre Benite Cedex , 69495, France
Investigational Site Number 250004
Rennes , 35033, France
Investigational Site Number 250005
Rouen Cedex , 76038, France
Investigational Site Number 250003
Villejuif Cedex , 94805, France
Investigational Site Number 276003
Frankfurt Am Main , 60590, Germany
Investigational Site Number 276002
Jena , 07747, Germany
Investigational Site Number 276001
Ulm , 89081, Germany
Investigational Site Number 528001
Amsterdam , 1105 , Netherlands
Investigational Site Number 528003
Groningen , 9713 , Netherlands
Investigational Site Number 528002
Rotterdam , 3075 , Netherlands

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

167

Study ID:

NCT01403636

Recruitment Status:

Completed

Sponsor:


Sanofi

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