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

Recruiting Phase 3 Interventional Study
Peripheral T Cell Lymphoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
504 (estimated)
Sponsor
Acrotech Biopharma Inc. · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patient with newly diagnosed, untreated histology-proven PTCL based on local pathology review who is eligible for receiving, Belinostat, Pralatrexate, and CHOP. Pathology material must be available at the site for each patient before enrollment so that it can be sent to the S…
Contacts

Uma Srinivas Atmuri, MPharm, MS

732-917-2420

uatmuri@acrotechbiopharma.com

CONTACT