RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
The urgent need for new effective therapy for T-cell lymphoma patients and promising results
observed so far in trials with RAD001(everolimus, mTOR inhibitor) strongly warrants the
investigation of RAD001 combined with CHOP as a first-line treatment in peripheral T-cell
lymphoma patients.
Thus, we designed a phase I/II study with the combination of RAD001 with CHOP chemotherapy
for newly diagnosed peripheral T-cell lymphoma patients.
Phase I
1. Primary objective
: To define the maximum tolerable dose
2. Secondary objective
- To evaluate the dose-limiting toxicity
- To evaluate the pharmacokinetics of RAD001
- Pharmacogenomic profiling
Phase II
1. Primary objective
: To evaluate the overall response rate
2. Secondary objective
- To estimate the time to progression
- To estimate overall survival
- Pharmacogenomic profiling
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Samsung Medical Center
Collaborators:
Asan Medical Center Korea Cancer Center Hospital National Cancer Center, Korea Yonsei University