chronic lymphocytic leukemia (CLL) non Hodgkin lymphoma (NHL)
Conditions
Interventions
A cycle is defined as 28 days of dosing with SAR245409.
Telephone safety assessments will be performed at specified intervals in
between site visits. Safety assessments (AEs, vital signs, electrocard
Sponsors
Sanofi-aventis
Eligibility
Age
18 Years to 99 Years
Inclusion 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 * Patient >
Exclusion criteria
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 - Central nervous system or leptomeningeal involvement - Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (anti-HCV) serology
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the objective response rate (ORR) as defined as the proportion of patients who experience complete response/remission (CR) or partial response/remission (PR) as defined by the International Working Group Response Criteria for malignant lymphoma (IWRC) and modified International Workshop on Chronic Lymphocytic Leukemia guidelines (IWCLL) (1, 2). All patients with MCL, FL or SLL meeting the criteria for CR must have a confirmatory FDG-PET scan no less than 6 weeks after the CR assessment. Patients with pretreatment bone marrow involvement (determined by biopsy, flow cytometry or IHC) will be considered a PR unless CR is confirmed by bone marrow biopsy, including molecular analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Main secondary endpoints will include: * Median PFS, proportion of patients with PFS at 6 months (24 weeks), duration of response * Safety (AEs and laboratory parameters). * Plasma concentrations of SAR245409 will be measured in cycle 1, 3 and 6. | — |
Countries
Netherlands
Outcome results
None listed