RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas

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

Timeline

Start

2010-07

Primary completion

2014-12

Completion

2014-12

Publications

• Banchi M, Cox MC, Bandini A, Orlandi P, Tacchi C, Stefanelli F, Chericoni S, Bocci G. Linifanib alone and in combination with metronomic chemotherapy is active on cutaneous T-cell lymphoma cells by targeting the AKT/mTOR signaling pathway. Invest New Drugs. 2025 Feb;43(1):135-146. doi: 10.1007/s10637-024-01501-8. Epub 2025 Jan 17.

Drugs

Indications