A Phase 2 study of SAR245409 in patients with relapsed or refractory mantle cell lymphoma, follicular lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma
- Conditions
- chronic lymphocytic leukemia (CLL)non Hodgkin lymphoma (NHL)1002432410025320
- Registration Number
- NL-OMON36096
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
* 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 ><= 18 years old
* ECOG performance status < <= 2
* Adequate white blood cells and hemoglobin
* Good kidney and liver function
* Fasting glucose < 160 mg/dL
* No other malignancy
* Use of adequate birth control
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint will be the objective response rate (ORR) as defined as<br /><br>the proportion of patients who experience complete response/remission (CR) or<br /><br>partial response/remission (PR) as defined by the International Working Group<br /><br>Response Criteria for malignant lymphoma (IWRC) and modified International<br /><br>Workshop on Chronic Lymphocytic Leukemia guidelines (IWCLL) (1, 2). All<br /><br>patients with MCL, FL or SLL meeting the criteria for CR must have a<br /><br>confirmatory FDG-PET scan no less than 6 weeks after the CR assessment.<br /><br>Patients with pretreatment bone marrow involvement (determined by biopsy, flow<br /><br>cytometry or IHC) will be considered a PR unless CR is confirmed by bone marrow<br /><br>biopsy, including molecular analysis. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Main secondary endpoints will include:<br /><br>* Median PFS, proportion of patients with PFS at 6 months (24 weeks), duration<br /><br>of response<br /><br>* Safety (AEs and laboratory parameters).<br /><br>* Plasma concentrations of SAR245409 will be measured in cycle 1, 3 and 6.</p><br>