Cutaneous T Cell Lymphoma Clinical Trial
Official title:
A Phase I/II Study of RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
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 I Level 1: RAD001 2.5 mg PO daily D1-14 + CHOP Level 2: RAD001 5 mg PO daily D1-14 + CHOP Level 3: RAD001 7.5 mg PO daily D1-14 + CHOP Level 4: RAD001 10 mg PO daily D1-14 + CHOP CHOP every 3 weeks D1 Cytoxan 750mg/m2 + D5W 100ml MIV over 1hr D1 Doxorubicin 50mg/m2 + D5W 100ml MIV over 30mins D1 Vincristine 1.4mg/m2 (max.2mg) IV push D1-D5 Prednisolone 100mg/d PO (40-30-30) Phase II Determined dosage of RAD001 + CHOP every 3 weeks Treatment will be continued until planned 6 cycles or disease progression ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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