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

NCT06072131 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2025-10-23

No results posted yet for this study

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.

Conditions

  • Peripheral T Cell Lymphoma

Interventions

DRUG

Belinostat Injection

Belinostat 600 mg/m2 or 1000 mg/m2 along with CHOP is given in each cycle

DRUG

Pralatrexate Injection

Pralatrexate 20 mg/m2 or 30 mg/m2 along with COP is given in each cycle

DRUG

CHOP

CHOP is the comparator arm

DRUG

COP

COP is given in combination with Pralatrexate

Sponsors & Collaborators

  • Acrotech Biopharma Inc.

    lead INDUSTRY

Principal Investigators

  • Uma Srinivas Atmuri, MPharm, MS · Acrotech Biopharma Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-04
Primary Completion
2030-07-31
Completion
2030-11-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Hungary
  • Italy
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06072131 on ClinicalTrials.gov