Spots Global Cancer Trial Database for RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
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Trial Identification
Brief Title: RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
Official Title: A Phase I/II Study of RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
Study ID: NCT01198665
Interventions
Study Description
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 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
Detailed Description: 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
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Cancer Center, Goyang-si, Kyoungki-do, Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Korea Cancer Center Hospital, Seoul, , Korea, Republic of
Yonsei Medical Center, Severance Hospital, Seoul, , Korea, Republic of
Contact Details
Name: Won Seog Kim, MD, PhD
Affiliation: Samsung Medical Center
Role: PRINCIPAL_INVESTIGATOR
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