Institut de canc rologie de la Loire(0.0 mi away)Contact
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Phase I of the study is designed to determine the recommended phase II dose (RP2D) for
tazemetostat in patients treated with 8 cycles of R-CHOP 21.
Phase II of the study is designed to determine the safety and the efficacy of tazemetostat in
DLBCL and FL patients :
DLBCL : tazemetostat with 6 cycles of R-CHOP 21 + 2 cycles of Rituximab FL : tazemetostat
with 6 cycles of R-CHOP 21 + 2 cycles of Rituximab then maintenance with 6 months of
tazemetostat and 24 months of Rituximab
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.
Up to 184 patients (122 DLBCL and 62 FL) will be recruited and treated with tazemetostat at
the MTD and RCHOP.
Patients will receive 6 cycles of RCHOP every 21 days and tazemetostat at the MTD every day,
starting on day 2 of cyle 1, + 2 cycles of Rituximab+tazemetostat. For FL, a maintenance of
tazemetostat (6 months) + rituximab (24 months) is expected
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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