To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL
A Phase 3, Randomized, Open-Label Study Comparing the Efficacy and Safety of the Combination of Beleodaq-CHOP or Folotyn-COP to the CHOP Regimen Alone in Newly Diagnosed Patients With Peripheral T-Cell Lymphoma
Acrotech Biopharma Inc.
504 participants
Oct 4, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Belinostat 600 mg/m2 or 1000 mg/m2 along with CHOP is given in each cycle
Pralatrexate 20 mg/m2 or 30 mg/m2 along with COP is given in each cycle
CHOP is the comparator arm
COP is given in combination with Pralatrexate
Locations(69)
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NCT06072131