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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

Part 1 (Dose Finding):
Primary Objective
To identify one of two dose-levels, each for belinostat and pralatrexate, that is optimal in polychemotherapy for the part 2 study based on safety and ORR at 3 months.

Part 2 (Efficacy and Safety):
Primary Objective
To compare the progression-free survival (PFS) of patients with newly diagnosed peripheral T-cell lymphoma (PTCL) treated for up to 6 cycles with belinostat in combination with CHOP (Bel-CHOP) or pralatrexate in combination with COP (Fol-COP) to CHOP alone

Secondary Objectives
To compare the overall survival (OS) for patients with newly diagnosed PTCL treated with Bel-CHOP or Fol-COP to CHOP alone
To compare the objective response rate for patients with newly diagnosed PTCL treated with Bel-CHOP or Fol-COP to CHOP alone
Treatment compliance

Exploratory Objectives
Dose intensity
To compare the duration of response for patients with newly diagnosed PTCL treated with Bel- CHOP or Fol-COP to CHOP alone
To compare the proportion of patients with newly diagnosed PTCL receiving hematopoietic stem cell transplantation who are treated with Bel-CHOP or Fol-COP to treatment with CHOP alone
Safety Objectives
To evaluate the safety profiles for patients with newly diagnosed PTCL treated with Bel-CHOP or Fol- COP compared to CHOP alone

Protocol Number: 012320
Phase: Phase III
Applicable Disease Sites: Non-Hodgkin's Lymphoma
Drugs Involved: Belinostat
Pralatrexate (Folotyn)
Principal Investigator: Yun Kyoung Tiger
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions:
  • RWJBarnabas Health
    • Jersey City Medical Center, Jersey City
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.