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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcrotech Biopharma Inc.

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-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 criteria

Qualifiers

Peripheral T-cell lymphoma, not otherwise specified

Angioimmunoblastic T-cell lymphoma

Anaplastic lymphoma kinase (ALK)-negative anaplastic large-cell lymphoma (ALCL) patients are eligible only if Brentuximab Vedotin (BV) is not commercially approved for use, not available in the country or patient is contraindicated to receive BV.

Follicular T-cell lymphoma

Disqualifiers

Precursor T-cell lymphoma or leukemia

Adult T-cell lymphoma/leukemia

T-cell prolymphocytic leukemia

T-cell large granular lymphocytic leukemia

Trial design

Treatments tested in this trial

  • Belinostat Injection
  • Pralatrexate Injection
  • CHOP
  • COP

Treatment groups

504 Participants
are divided into 5 treatment groups

Locations

69
Canada
The Ottawa HospitalK1H 8L6, OttawaOntario, Canada
Princess Margaret HospitalM5G 2C4, TorontoOntario, Canada
Germany
Universitatsmedizin Gottingen37075, Göttingen Germany
Universitaetsklinikum Halle (Saale)06120, Halle Germany

Sponsors and collaborators

Acrotech Biopharma Inc.

Lead sponsor