RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas (NCT01198665) | Clinical Trial Compass
CompletedPhase 1/2
RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
South Korea46 participantsStarted 2010-07
Plain-language 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
Who can participate
Age range20 Years – 70 Years
SexALL
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