To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL
Status:
Recruiting
Trial end date:
2030-11-01
Target enrollment:
Participant gender:
Summary
Part 1: This is a 5 Arm study primarily to determine the best dose out of the two dose levels
of Belinostat and Pralatrexate combined with CHOP/COP in newly diagnosed PTCL patients based
on Safety for part 2 study.
Part 2 (Efficacy and Safety): This is a 3 Arm study. Patients with previously untreated PTCL
will be randomized 1:1:1 into 1 of 3 treatment groups: 2 experimental treatment groups
(Bel-CHOP or Fol-COP) or 1 active comparator treatment group (CHOP). Patients will be treated
for up to 6 cycles. The primary objective is to compare the Progression Free Survival of
patients with newly diagnosed PTCL treated for up to 6 cycles with Beleodaq (belinostat) in
combination with CHOP (Bel-CHOP) or Folotyn (pralatrexate injection) in combination with COP
(Fol-COP) to CHOP alone.