Study Combining SAR245409 With Rituximab or Bendamustine Plus Rituximab in Patients With Indolent Lymphoma, Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia
- Conditions
- Indolent Non-Hodgkin LymphomaMantle Cell LymphomaChronic Lymphocytic Leukemia
- Interventions
- Registration Number
- NCT01410513
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
- To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for SAR245409 when administered in combination with rituximab or bendamustine plus rituximab
Secondary Objectives:
* To determine the safety and tolerability of SAR245409 in combination with rituximab or bendamustine plus rituximab in subjects with indolent Hon-Hodgkin Lymphoma (iNHL) Mantle Cell Lymphoma (MCL) or Chronic Lymphocytic Leukemia (CLL)
* To determine the pharmacokinetics (PK) of SAR245409, bendamustine and rituximab when used in combination in subjects with iNHL, MCL or CLL
* To determine the pharmacodynamic (PD) effects of SAR245409 in combination with rituximab or bendamustine plus rituximab in subjects with iNHL, MCL or CLL
* To determine the antitumor activity of SAR245409 in combination with rituximab or bendamustine plus rituximab in subjects with iNHL, MCL or CLL
- Detailed Description
All subjects will take SAR245409 twice daily. All subjects will receive SAR245409 as long as there is clinical benefit.
Combination therapy with SAR245409, bendamustine and rituximab , will be administered over a 28 day cycle for up to 6 to 8 cycles.
Subjects receiving the doublet combination , SAR245409 plus rituximab will receive weekly rituximab for 4 - 8 weeks. Monthly Rituximab may be continued beyond 8 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR245409 + rituximab + bendamustine (iNHL, MCL) SAR245409 Subjects will receive oral SAR245409 twice daily continuously and monthly bendamustine intravenously. SAR245409 + rituximab SAR245409 Subjects will receive oral SAR245409 twice daily continuously and weekly rituximab intravenously SAR245409 + rituximab+ bendamustine (CLL) SAR245409 Subjects will receive oral SAR245409 twice daily continuously and monthly bendamustine and rituximab intravenously
- Primary Outcome Measures
Name Time Method Identification Of Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) 4 weeks to 8 weeks
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (AUC0-7h) of rituximab up to 2 months Pharmacokinetics (AUC0-12h) of SAR245409 up to 2 months Pharmacokinetics (tmax) of bendamustine up to 2 months Number of subjects with treatment emergent adverse events Time from receiving first dose of SAR245409 until 30 days after the last dose Pharmacokinetics (tmax) of SAR245409 up to 2 months Pharmacokinetics (Ctrough) of SAR245409 up to 2 months Pharmacokinetics (AUC) of bendamustine up to 2 months Pharmacokinetics (AUClast) of bendamustine up to 2 months Pharmacokinetics (Ceoi) of bendamustine up to 2 months Pharmacokinetics (Cl) of bendamustine up to 2 months Pharmacokinetics (Cmax) of SAR245409 up to 2 months Pharmacokinetics (Vss) of bendamustine up to 2 months Efficacy as determined by objective response rate (ORR) up to 4 years Pharmacokinetics (Ceoi) of rituximab up to 2 months Pharmacokinetics (tmax) of rituximab up to 2 months
Trial Locations
- Locations (3)
Investigational Site Number 840006
🇺🇸Augusta, Georgia, United States
Investigational Site Number 840002
🇺🇸Charleston, South Carolina, United States
Investigational Site Number 840004
🇺🇸Aurora, Colorado, United States