Clinical Trial: RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase I/II Study of RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
Brief 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
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Primary objective
: To define the maximum tolerable dose
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Secondary objective
- To evaluate the dose-limiting toxicity
- To evaluate the pharmacokinetics of RAD001
- Pharmacogenomic profiling
Phase II
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Primary objective
: To evaluate the overall response rate
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Secondary objective
- To estimate the time to progression
- To estimate overall survival
- Pharmacogenomic profiling
Detailed Summary: 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
Sponsor: Samsung Medical Center
Current Primary Outcome: determination of the maximum tolerable dose and evaluation of response rate [ Time Frame: Phase I for maximal tolerable dose and phase II for efficacy ]
Original Primary Outcome: Same as current
Current Secondary Outcome: doe-limiting toxicity and pharmacogenomics [ Time Frame: Phase I/II ]
Phase I
- To evaluate the dose-limiting toxicity
- To evaluate the pharmacokinetics of RAD001
- Pharmacogenomic profiling Phase II
- To estimate the time to progression
- To estimate overall survival
- Pharmacogenomic profiling
Original Secondary Outcome: Same as current
Information By: Samsung Medical Center
Dates:
Date Received: September 8, 2010
Date Started: July 2010
Date Completion:
Last Updated: March 1, 2015
Last Verified: March 2015