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Belinostat or Pralatrexate with CHOP for Peripheral T-Cell Lymphoma

This study is looking at new ways to treat Peripheral T-Cell Lymphoma (PTCL), a type of cancer. It compares two drug combinations, Belinostat with CHOP, and Pralatrexate with COP, against CHOP alone. CHOP and COP are standard chemotherapy treatments. The study aims to find out if adding Belinostat or Pralatrexate improves how long patients live without their cancer getting worse (Progression-Free Survival, or PFS). You might be able to join if you are an adult with newly diagnosed PTCL and haven't been treated for it yet. The study will enroll 504 participants and will measure PFS over 4.5 years.

Study design
This is a randomized, open-label study with 504 participants. It has two parts: Part 1 finds the best dose of Belinostat and Pralatrexate, and Part 2 compares the effectiveness of the chosen doses against standard treatment.
What's involved
Participants will receive treatment for up to 6 cycles. The study involves receiving Belinostat or Pralatrexate injections along with CHOP or COP.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study, Progression-Free Survival, will be measured at 4.5 years, indicating a long-term follow-up.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06072131

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Acrotech Biopharma Inc.
~504 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Belinostat InjectionPralatrexate InjectionCHOPCOP

At a glance

Recruiting sites
57 of 69 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PFS
Measured over 4.5 years

Conditions

Peripheral T Cell Lymphoma

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NCT06072131

Where you'd take part

This study runs at 69 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Adana City Education and Research Hospital

    Adana, Turkey (Türkiye)study coordinator listed

    Recruiting

  • Ajou University Hospital

    Suwon, Gyenoggi-do, South Koreastudy coordinator listed

    Recruiting

  • Andras Josa University Teaching Hospital

    Nyíregyháza, Szent Istvan Utca, Hungarystudy coordinator listed

    Recruiting

  • Ankara University Medical Faculty Hospital

    Altındağ, Ankara, Turkey (Türkiye)study coordinator listed

    Recruiting

  • Asan Medical Center

    Songpa-dong, Seoul, South Koreastudy coordinator listed

    Recruiting

  • Azienda Ospedaliera Cardinale Giovanni Panico

    Tricase, Apulia, Italystudy coordinator listed

    Recruiting

  • Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo

    Alessandria, Italystudy coordinator listed

    Recruiting

  • Azienda Ospedaliera Universitaria di Parma

    Parma, Italystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Uma Srinivas Atmuri, MPharm, MS
[email protected]
732-917-2420
Email the study team

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Eligibility criteria

Inclusion

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
Others: Extra-nodal natural killer/T-cell lymphoma, nasal type; enteropathy-associated T-cell lymphoma; hepatosplenic T-cell lymphoma; and subcutaneous panniculitis-like T-cell lymphoma 2. CD30 expression and T-cell Follicular Helper (TFH) phenotype status must be available for documentation. 2. Patient has at least 1 site of measurable disease according to Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria as assessed by the local Investigator (Appendix 3) 3. Patient has an Eastern Cooperative Oncology Group performance (ECOG) status ≤2 4. For Part 1 (Dose Finding) - Patient has adequate hematological, hepatic, and renal function as defined by:

What this trial measures

  • PFS4.5 years

    Progression-free survival is determined from randomization to the first documented Progression of Disease or death, whichever occurs first.