RecruitingPhase III🇵🇱 PolandEN originalLymphoma

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Nowo rozpoznany, nielechony chłoniak T-komórkowy potwierdzony badaniem histologicznego
  • Dostępny materiał do badania patologicznego przed włączeniem do badania
  • Co najmniej jedno widoczne ognisko choroby dające się zmierzyć
  • Dobry stan ogólny (możliwość wykonywania codziennych czynności)
  • Prawidłowe wyniki badań krwi, wątroby i nerek

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 22, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (69)

University of California, San Francisco Fresno

Clovis, United States

University of California, Los Angeles Hem/ Onc Clinical Research Unit, Suite 600

Santa Monica, United States

University of Colorado School of Medicine

Aurora, United States

Moffitt Malignant Hematology & Cellular Therapy at Memorial Healthcare System Memorial Cancer Institute

Pembroke Pines, United States

Norton Cancer Institute

Louisville, United States

Henry Ford Health System

Detroit, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, United States

Valley Cancer Associates

Harlingen, United States

Houston Methodist Hospital

Houston, United States

University of Texas, MD Anderson Cancer Center

Houston, United States

Baylor Scott & White Medical Center - Temple

Temple, United States

The Ottawa Hospital

Ottawa, Canada

Princess Margaret Hospital

Toronto, Canada

Universitatsmedizin Gottingen

Göttingen, Germany

Universitaetsklinikum Halle (Saale)

Halle, Germany

University of Debrecen Clinical Center

Debrecen, Hungary

Andras Josa University Teaching Hospital

Nyíregyháza, Hungary

Semmelweis Egyetem

Budapest, Hungary

National Institute of Oncology

Budapest, Hungary

Markhot Ferenc Oktato Korhaz

Eger, Hungary

Belgyogyaszati Klinika es Kardiologiai Kozpont

Szeged, Hungary

Azienda Ospedaliera Cardinale Giovanni Panico

Tricase, Italy

University of Milano Bicocca

Milan, Italy

Servizio Sanitario Regionale Emilia-Romagna-Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl (IRST)

Meldola, Italy

Policlinico GB Rossi Borgo Roma

Borgo Roma, Italy

Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo

Alessandria, Italy

Ospedale Policlinico San Martino, IRCCS

Genova, Italy

Azienda Ospedaliera Universitaria di Parma

Parma, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Azienda USL di Ravenna

Ravenna, Italy

University Hospital in Wroclaw

Wroclaw, Poland

Pratia MCM Krakow

Krakow, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Warsaw, Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

Lodz, Poland

Inje University Busan Paik Hospital

Busan, South Korea

Ulsan University Hospital

Ulsan, South Korea

Ajou University Hospital

Suwon, South Korea

The Catholic University of Korea - St. Vincents Hospital

Suwon, South Korea

Gyeongsang National University Hospital

Jinju, South Korea

Jeonbuk National University Hospital

Jeonju, South Korea

Yeungnam University Medical Center

Daegu, South Korea

Severance hospital, Yonsei University

Sinchon-dong, South Korea

Asan Medical Center

Songpa-dong, South Korea

Daegu Catholic University Medical Center

Daegu, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Hospital Universitario Basurto

Bilbao, Spain

Hospital Universitario Fundación Jiménez Díaz

Moncloa-Aravaca, Spain

Hospital Universitario de Navarra

Pamplona, Spain

Hospital del Mar Medical Research Institute

Barcelona, Spain

ICO - Hospital Duran i Reynals

Barcelona, Spain

Clinica Universidad de Navarra - Madrid

Madrid, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Hospital Universitario y Politecnico La Fe

Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Changhua Christian Hospital CCH

Changhua, Taiwan

Hualien Tzu Chi Medical Center

Hualien City, Taiwan

National Cheng Kung University Hospital NCKUH

Tainan, Taiwan

Chang Bing Show Chwan Memorial Hospital

Changhua, Taiwan

Hematology Oncology Taipei Medical University - Shuang-Ho Hospital

New Taipei City, Taiwan

Chang Gung Memorial Hospital Linkou Branch

Taoyuan, Taiwan

Ankara University Medical Faculty Hospital

Altındağ, Turkey (Türkiye)

Bilkent University

Çankaya, Turkey (Türkiye)

Gazi University Faculty of Medicine

Yenimahalle, Turkey (Türkiye)

VKV AMERICAN HOSPITAL, Medical Oncology Outpatient Clinic

Şişli, Turkey (Türkiye)

Adana City Education and Research Hospital

Adana, Turkey (Türkiye)

Ege Univ. Hospital

Bornova, Turkey (Türkiye)

Trial contact

Uma Srinivas Atmuri, MPharm, MS

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/23/2026.

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