Last updated on July 2017

Study of Tazemetostat in Newly Diagnosed Diffuse Large B Cell Lymphoma Patients Treated by Chemiotherapy


Brief description of study

Phase I of the study is designed to determine the recommended phase II dose (RP2D) for tazemetostat in patients treated with R-CHOP 21. Phase II of the study is designed to determine the safety of tazemetostat in patients treated with 8 cycles of R-CHOP 21 and to determine the complete response rate according to Cheson International Working Group (IWG) 2014: Lugano Classification (i.e. Deauville scale 1-3) after 8 cycles of Epi-RCHOP 21.

Detailed Study Description

Phase I: Up to 18 patients will be recruited, using a conventional dose-escalation algorithm (3+3 patients per dose level) to identify the maximum tolerated dose (MTD) which will be deemed the RP2D. Patients will receive 8 cycles of RCHOP every 21 days and tazemetostat every day, starting on day 2 of cycle 1. 4 cohorts are defined, according to dose levels of tazemetostat: 400mg Twice a day (BID) (cohort 1, starting level), 600mg BID (cohort 2), 800mg BID (cohort 3), 200mg BID (cohort -1), depending on the observed toxicities. Phase II: Up to 115 patients will be recruited and treated with tazemetostat at the MTD and RCHOP. Patients will receive 8 cycles of RCHOP every 21 days and tazemetostat at the MTD every day, starting on day 2 of cyle 1.

Clinical Study Identifier: NCT02889523

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Franck MORSCHHAUSER, Pr

CHRU Lille - H pital Claude Huriez
Lille Cedex, France
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Steven LE GOUILL, Pr

CHU de Nantes - H tel Dieu
Nantes, France
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Gilles SALLES, Pr

CHU Lyon Sud
Pierre-Bénite Cedex, France
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Hervé TILLY, Pr

Centre Henri Becquerel
Rouen, France
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Vincent RIBRAG, Pr

Institut Gustave Roussy
Villejuif, France
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