The Combination of Rad001 and Rituximab In Patients With Non-hodgkin's Lymphomas
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
This study is an open label, multicenter study with two phases:
- Phase I is a dose escalation study of RAD001 in combination with one injection of
Rituximab 375 mg/m² per week during 4 weeks (28 days) in patients CD20 positive
non-Hodgkin's lymphomas to determine the dose limiting toxicities (DLTs) and maximum
tolerated dose (MTD). The purpose of the study is to assess the feasibility of the
combination based on - rate of dose limiting toxicities (DLT) and PK drug-drug
interaction (DDI).
- Phase II will define the efficacy and safety profile of RAD001 and Rituximab combination
at the RP2D in patients with lymphomas.
Patients with lymphomas will be treated at the RP2D established during phase I and evaluated
for clinical benefit rate, comprising complete responses (CR + CRu), partial responses (PR)
and stable disease (SD), and time to progression using the IWG criteria for treatment
response.
Induction therapy will follow the same schedule than during the phase I study.
Maintenance therapy: Monthly cycles for up to 2 years with:
- Daily RAD001 at the same dose than during induction therapy.
- Rituximab infusion every other cycle at 375 mg/m2 that correspond to the usual
maintenance schedule for Rituximab.
Response to therapy will be assessed between day 42 and day 49, then every two months.