To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL (NCT06072131)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California, San Francisco Fresno — Clovis, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (69 Sites)
Showing the first 25 of 69 sites.
- University of California, San Francisco Fresno — Clovis, California
- University of California, Los Angeles Hem/ Onc Clinical Research Unit, Suite 600 — Santa Monica, California
- University of Colorado School of Medicine — Aurora, Colorado
- Moffitt Malignant Hematology & Cellular Therapy at Memorial Healthcare System Memorial Cancer Institute — Pembroke Pines, Florida
- Norton Cancer Institute — Louisville, Kentucky
- Henry Ford Health System — Detroit, Michigan
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
- Valley Cancer Associates — Harlingen, Texas
- Houston Methodist Hospital — Houston, Texas
- University of Texas, MD Anderson Cancer Center — Houston, Texas
- Baylor Scott & White Medical Center - Temple — Temple, Texas
- The Ottawa Hospital — Ottawa, Ontario
- Princess Margaret Hospital — Toronto, Ontario
- Universitatsmedizin Gottingen — Göttingen,
- Universitaetsklinikum Halle (Saale) — Halle,
- University of Debrecen Clinical Center — Debrecen, Nagyerdei Krt. 98
- Andras Josa University Teaching Hospital — Nyíregyháza, Szent Istvan Utca
- Semmelweis Egyetem — Budapest,
- National Institute of Oncology — Budapest,
- Markhot Ferenc Oktato Korhaz — Eger,
- Belgyogyaszati Klinika es Kardiologiai Kozpont — Szeged,
- Azienda Ospedaliera Cardinale Giovanni Panico — Tricase, Apulia
- University of Milano Bicocca — Milan, Bicocca
- Servizio Sanitario Regionale Emilia-Romagna-Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl (IRST) — Meldola, Province Of Forlì-Cesena
- Policlinico GB Rossi Borgo Roma — Borgo Roma, Verona
📞 Contact the Study Coordinator
Phone: (732) 917-2420
Email: uatmuri@acrotechbiopharma.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Peripheral T Cell Lymphoma
- A Phase II, Single-center, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib in the Management of Newly Diagnosed Peripheral T Cell Lymphoma Patients (GOLDEN Study) and Correlative Study — Houston, Texas
- CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma — Chapel Hill, North Carolina
- Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma — Scottsdale, Arizona
Explore by condition: All Peripheral T Cell Lymphoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.