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Phase 3RecruitingPriority 1 · Highest priorityNCT06072131

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

ClinicalTrials.gov

Plain-language summary

This Phase 3 trial is comparing different first-line treatment approaches for people newly diagnosed with T-cell lymphoma. Patients are randomly assigned to different treatment groups to see which approach works best. It is available at 11 US locations across multiple states.

Who can join (key eligibility)

  • Age 18 Years or older
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

Belinostat Injection (DRUG): Belinostat 600 mg/m2 or 1000 mg/m2 along with CHOP is given in each cycle | Pralatrexate Injection (DRUG): Pralatrexate 20 mg/m2 or 30 mg/m2 along with COP is given in each cycle | CHOP (DRUG): CHOP is the comparator arm | COP (DRUG): COP is given in combination with Pralatrexate

Drugs / treatments
Belinostat Injection, Pralatrexate Injection, CHOP, COP
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

At a glance

Phase
Phase 3
Status
Recruiting
Design
Randomized, open-label
Enrollment target
504 patients
Primary endpoint
PFS
Ages
18 Years to —
Start date
2023-10-04
Est. completion
2030-11

Locations

11 US sites · 69 total

CaliforniaColoradoFloridaKentuckyMichiganNew JerseyTexas

Contact

Sponsor
Acrotech Biopharma Inc. (INDUSTRY)
Contact
Uma Srinivas Atmuri, MPharm, MS | uatmuri@acrotechbiopharma.com | 732-917-2420

Tags

All T-cell lymphomasNewly diagnosedRelapsed/Refractory
TrialCompass — Clinical Trial Summary

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

NCT06072131

Phase: Phase 3 | Status: Recruiting | Priority: Highest

Plain-language summary

This Phase 3 trial is comparing different first-line treatment approaches for people newly diagnosed with T-cell lymphoma. Patients are randomly assigned to different treatment groups to see which approach works best. It is available at 11 US locations across multiple states.

Who can join

  • Age 18 Years or older
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

What's being tested

Belinostat Injection (DRUG): Belinostat 600 mg/m2 or 1000 mg/m2 along with CHOP is given in each cycle | Pralatrexate Injection (DRUG): Pralatrexate 20 mg/m2 or 30 mg/m2 along with COP is given in each cycle | CHOP (DRUG): CHOP is the comparator arm | COP (DRUG): COP is given in combination with Pralatrexate

Drugs / treatments: Belinostat Injection, Pralatrexate Injection, CHOP, COP

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Randomized, open-label

Enrollment target: 504 patients

Primary endpoint: PFS

Ages: 18 Years to —

Start date: 2023-10-04 | Est. completion: 2030-11

Locations

11 US sites · 69 total

California, Colorado, Florida, Kentucky, Michigan, New Jersey, Texas

Contact

Uma Srinivas Atmuri, MPharm, MS | uatmuri@acrotechbiopharma.com | 732-917-2420

Sponsor: Acrotech Biopharma Inc. (INDUSTRY)

Tags

All T-cell lymphomas · Newly diagnosed · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT06072131

Prepared using TrialCompass (trialcompass.com) on June 19, 2026. For informational purposes only. Always discuss with your healthcare team.
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Data sourced from ClinicalTrials.gov.

For informational purposes only. Not medical advice — always consult your healthcare team.

Built with care for the rare cancer community.

Data last updated: June 2026

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