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A Phase I/II Study of RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas (RADCHOP)

NCT01198665 Phase 1/Phase 2 COMPLETED

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

Details

Lead sponsorSamsung Medical Center
PhasePhase 1/Phase 2
StatusCOMPLETED
Enrolment46
Start date2010-07
Completion2014-12

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Interventions

Primary outcomes

Countries

South Korea