Spots Global Cancer Trial Database for A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia
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Trial Identification
Brief Title: A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia
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
Study ID: NCT01403636
Conditions
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigational Site Number 840012, Los Angeles, California, United States
Investigational Site Number 840104, Fort Meyers, Florida, United States
Investigational Site Number 840006, Augusta, Georgia, United States
Investigational Site Number 840011, Maywood, Illinois, United States
Investigational Site Number 840010, Kansas City, Kansas, United States
Investigational Site Number 840013, Lexington, Kentucky, United States
Investigational Site Number 840007, Paducah, Kentucky, United States
Investigational Site Number 840004, Boston, Massachusetts, United States
Investigational Site Number 840015, St Louis, Missouri, United States
Investigational Site Number 840014, Canton, Ohio, United States
Investigational Site Number 840001, Philadelphia, Pennsylvania, United States
Investigational Site Number 840002, Morgantown, West Virginia, United States
Investigational Site Number 036002, Clayton, , Australia
Investigational Site Number 036001, Hobart, , Australia
Investigational Site Number 036005, Kingswood, , Australia
Investigational Site Number 036003, Perth, , Australia
Investigational Site Number 056003, Bruxelles, , Belgium
Investigational Site Number 056002, Gent, , Belgium
Investigational Site Number 056001, Leuven, , Belgium
Investigational Site Number 250002, Montpellier, , France
Investigational Site Number 250001, Pierre Benite Cedex, , France
Investigational Site Number 250004, Rennes, , France
Investigational Site Number 250005, Rouen Cedex, , France
Investigational Site Number 250003, Villejuif Cedex, , France
Investigational Site Number 276003, Frankfurt Am Main, , Germany
Investigational Site Number 276002, Jena, , Germany
Investigational Site Number 276001, Ulm, , Germany
Investigational Site Number 528001, Amsterdam, , Netherlands
Investigational Site Number 528003, Groningen, , Netherlands
Investigational Site Number 528002, Rotterdam, , Netherlands
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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