New hope for rare blood cancer: Two-Drug combo trial launches

NCT ID NCT06072131

First seen Jun 25, 2026 · Last updated Jul 23, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether adding either belinostat or pralatrexate to standard chemotherapy helps people with newly diagnosed peripheral T-cell lymphoma live longer without their cancer getting worse. About 504 participants will be randomly assigned to one of three treatment groups. The study first finds the safest dose, then compares the combinations to chemotherapy alone.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
Belinostat (Beleodaq) and pralatrexate (Folotyn), combined with standard chemotherapy (CHOP or COP)
What this could lead to
If successful, this could offer a more effective first-line treatment for peripheral T-cell lymphoma, potentially improving how long patients live without their cancer worsening.
What could go wrong
This is an early-phase dose-finding study (Part 1) before the main comparison. Adding new drugs to chemotherapy may increase side effects, and it's unknown if the combinations will outperform standard care.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Adana City Education and Research Hospital

    RECRUITING

    Adana, 4522, Turkey (Türkiye)

  • Ajou University Hospital

    RECRUITING

    Suwon, Gyenoggi-do, 16499, South Korea

  • Andras Josa University Teaching Hospital

    RECRUITING

    Nyíregyháza, Szent Istvan Utca, 68, Hungary

  • Ankara University Medical Faculty Hospital

    RECRUITING

    Altındağ, Ankara, 06230, Turkey (Türkiye)

  • Asan Medical Center

    RECRUITING

    Songpa-dong, Seoul, 05505, South Korea

  • Azienda Ospedaliera Cardinale Giovanni Panico

    RECRUITING

    Tricase, Apulia, 73039, Italy

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

    RECRUITING

    Alessandria, Italy

  • Azienda Ospedaliera Universitaria di Parma

    RECRUITING

    Parma, 43126, Italy

  • Azienda USL di Ravenna

    RECRUITING

    Ravenna, 41800, Italy

  • Baylor Scott & White Medical Center - Temple

    RECRUITING

    Temple, Texas, 76508, United States

  • Belgyogyaszati Klinika es Kardiologiai Kozpont

    RECRUITING

    Szeged, 6725, Hungary

  • Bilkent University

    RECRUITING

    Çankaya, Ankara, 06800, Turkey (Türkiye)

  • Chang Bing Show Chwan Memorial Hospital

    RECRUITING

    Changhua, 505, Taiwan

  • Chang Gung Memorial Hospital Linkou Branch

    WITHDRAWN

    Taoyuan, 333, Taiwan

  • Changhua Christian Hospital CCH

    WITHDRAWN

    Changhua, Changhua County, Taiwan

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Clinica Universidad de Navarra - Madrid

    RECRUITING

    Madrid, 28027, Spain

  • Daegu Catholic University Medical Center

    WITHDRAWN

    Daegu, 42472, South Korea

  • Ege Univ. Hospital

    RECRUITING

    Bornova, 35100, Turkey (Türkiye)

  • Fondazione IRCCS Policlinico San Matteo

    RECRUITING

    Pavia, 27100, Italy

  • Gachon University Gil Medical Center

    RECRUITING

    Incheon, 21565, South Korea

  • Gazi University Faculty of Medicine

    RECRUITING

    Yenimahalle, Ankara, 06560, Turkey (Türkiye)

  • Gyeongsang National University Hospital

    WITHDRAWN

    Jinju, Gyeongsangnam-do, South Korea

  • Hematology Oncology Taipei Medical University - Shuang-Ho Hospital

    RECRUITING

    New Taipei City, Taiwan

  • Henry Ford Health System

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hospital Universitario Basurto

    RECRUITING

    Bilbao, Bizkaia, 48013, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Moncloa-Aravaca, Madrid, 28040, Spain

  • Hospital Universitario Miguel Servet

    WITHDRAWN

    Zaragoza, 50009, Spain

  • Hospital Universitario de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Hospital Universitario de Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • Hospital Universitario y Politecnico La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital del Mar Medical Research Institute

    RECRUITING

    Barcelona, 08003, Spain

  • Houston Methodist Hospital

    WITHDRAWN

    Houston, Texas, 77030, United States

  • Hualien Tzu Chi Medical Center

    WITHDRAWN

    Hualien City, Hualien, 970, Taiwan

  • ICO - Hospital Duran i Reynals

    RECRUITING

    Barcelona, 08908, Spain

  • Inje University Busan Paik Hospital

    RECRUITING

    Busan, Busanjin District, South Korea

  • Jeonbuk National University Hospital

    WITHDRAWN

    Jeonju, Jeollabuk-do, South Korea

  • Markhot Ferenc Oktato Korhaz

    WITHDRAWN

    Eger, 3300, Hungary

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

    RECRUITING

    Pembroke Pines, Florida, 33026, United States

  • Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

    RECRUITING

    Warsaw, Poland

  • National Cheng Kung University Hospital NCKUH

    RECRUITING

    Tainan, Southern Taiwan, 704, Taiwan

  • National Institute of Oncology

    RECRUITING

    Budapest, 1122, Hungary

  • Norton Cancer Institute

    RECRUITING

    Louisville, Kentucky, 40207, United States

  • Ospedale Policlinico San Martino, IRCCS

    RECRUITING

    Genova, 16132, Italy

  • Policlinico GB Rossi Borgo Roma

    RECRUITING

    Borgo Roma, Verona, 37134, Italy

  • Pratia MCM Krakow

    RECRUITING

    Krakow, 30-727, Poland

  • Princess Margaret Hospital

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Samsung Medical Center

    WITHDRAWN

    Seoul, 6351, South Korea

  • Semmelweis Egyetem

    RECRUITING

    Budapest, 1088, Hungary

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

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

    RECRUITING

    Meldola, Province Of Forlì-Cesena, 47014, Italy

  • Severance hospital, Yonsei University

    RECRUITING

    Sinchon-dong, Seoul, South Korea

  • The Catholic University of Korea - St. Vincents Hospital

    RECRUITING

    Suwon, Gyeonggi-do, South Korea

  • The Ottawa Hospital

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • Ulsan University Hospital

    WITHDRAWN

    Ulsan, Dong-gu, South Korea

  • Universitaetsklinikum Halle (Saale)

    RECRUITING

    Halle, 06120, Germany

  • Universitatsmedizin Gottingen

    RECRUITING

    Göttingen, 37075, Germany

  • University Hospital in Wroclaw

    RECRUITING

    Wroclaw, Wroclaw, 50-367, Poland

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

    RECRUITING

    Santa Monica, California, 90404, United States

  • University of California, San Francisco Fresno

    RECRUITING

    Clovis, California, 93611, United States

  • University of Colorado School of Medicine

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Debrecen Clinical Center

    RECRUITING

    Debrecen, Nagyerdei Krt. 98, 4032, Hungary

  • University of Milano Bicocca

    RECRUITING

    Milan, Bicocca, 20126, Italy

  • University of Texas, MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • VKV AMERICAN HOSPITAL, Medical Oncology Outpatient Clinic

    RECRUITING

    Şişli, Istanbul, 34365, Turkey (Türkiye)

  • Valley Cancer Associates

    WITHDRAWN

    Harlingen, Texas, 78550, United States

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

    RECRUITING

    Lodz, Łódź Voivodeship, 93-513, Poland

  • Yeungnam University Medical Center

    RECRUITING

    Daegu, Nam-gu, South Korea

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