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First received: September 19, 2023

Clinical Trial: To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL

Study Status: Completed

Recruit Status: RECRUITING

Condition: Peripheral T Cell Lymphoma

Study Type: INTERVENTIONAL


Official Title: 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-Cel

Brief 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…

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