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

  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 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