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

NCT ID NCT06072131

Disease control Sponsor: Acrotech Biopharma Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 504 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Nov 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient with newly diagnosed, untreated histology-proven PTCL based on local pathology review who is eligible for receiving, Belinostat, Pralatrexate, and CHOP. Pathology material must be available at the site for each patient before enrollment so that it can be sent to the Sponsor (or designee) for later confirmation. The following subtypes, as defined by the updated World Health Organization (WHO) classification, may be included. This information should be available for eligibility: 1. Pathology subtype: * 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: 1. Absolute neutrophil count ≥ 1.5 × 10⁹/L or ≥ 1.0 × 10⁹/L if evidence of bone marrow involvement 2. Platelet count ≥100×10⁹/L or ≥ 75×10⁹/L if evidence of bone marrow involvement 3. Total bilirubin ≤1.5 mg/dL 4. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 3×upper limit of normal (ULN; AST/ALT ≤5×ULN if documented hepatic involvement with lymphoma) 5. Calculated creatinine clearance of ≥ 60 mL/min 5. Part 2 (Efficacy and Safety) - disease related hypoplasia, hepatological or renal dysfunction can be included if any of the treatment groups can be administered based on package insert recommendation with the following restrictions: 1. Absolute neutrophil count ≥ 1.5 × 10⁹/L or ≥ 1.0 × 10⁹/L if evidence of bone marrow involvement 2. Platelet count ≥100×10⁹/L or ≥ 75×10⁹/L if evidence of bone marrow involvement 3. Total bilirubin ≤1.5 mg/dL 4. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 3 x the upper limit of normal (ULN; AST/ALT ≤5×ULN if documented hepatic involvement with lymphoma) 5. Calculated creatinine clearance of ≥ 60 mL/min 6. UGT1A1 genotype has been characterized (see Belinostat dose modifications if abnormal) and must be available for documentation. 7. Patient must be willing and capable of giving written informed consent and must be able to adhere to dosing and visit schedules and meet all study requirements 8. Patient (male or female) is at least 18 years of age at the time of informed consent 9. Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 6 months after the last dose of study treatment. 10. Females of childbearing potential must have a negative urine pregnancy test within 4 weeks prior to the first day of study treatment. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test. Exclusion Criteria: A patient will not be eligible for inclusion if ANY of the criteria listed below apply: 1. Patients with a diagnosis of: 1. Precursor T-cell lymphoma or leukemia 2. Adult T-cell lymphoma/leukemia 3. T-cell prolymphocytic leukemia 4. T-cell large granular lymphocytic leukemia 5. Primary cutaneous type ALCL 6. Cutaneous T-cell lymphoma (mycosis fungoides/Sezary syndrome) 7. ALCL if they can be treated with Brentuximab Vedotin (BV) 2. Patients taking drugs which are potent UGT1A1 inhibitors must discontinue one week before randomization; drug can be resumed if the treatment doesn't include belinostat 3. Patient with an active concurrent malignancy/life-threatening disease with the exception of non melanoma skin tumors and in situ cervical cancer if they have received treatment resulting in complete resolution of the cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease. If there is a history of prior malignancies/life-threatening diseases, the patient must be disease free for at least 5 years 4. Prior histone deacetylase (HDAC) inhibitor or pralatrexate therapy 5. Any known cardiac abnormalities such as baseline prolongation of QT/corrected QT (QTc) interval (i.e. demonstration of a QTc interval \>450 msec); long QT syndrome; myocardial infarction within 6 months prior to starting study; history of significant cardiovascular disease; the required use of a concomitant medication that may cause Torsades de Pointes 6. Patient with uncontrolled hypertension 7. Patients status on the following: 1. Has a known HIV-positive diagnosis with uncontrolled and detectable viral load 2. Has Hepatitis B or Hepatitis C virus diagnosis with uncontrolled and detectable viral load or immunological evidence of chronic active disease 8. Patient with central nervous system metastasis 9. Patient with an active uncontrolled infection, underlying medical condition, laboratory abnormality, or other serious illness that would impair the ability of the patient to receive protocol treatment 10. Patient who has used any investigational drugs, biologics, or devices within 28 days prior to study treatment or plans to use any of these during the course of the study 11. Patient with a known history of drug or alcohol abuse 12. Pregnant or breastfeeding women

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Conditions

The condition(s) this trial relates to.

ALK-negative anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma enteropathy-associated T-cell lymphoma extranodal nasal NK/T cell lymphoma hepatosplenic T-cell lymphoma mature T-cell and NK-cell non-Hodgkin lymphoma Nodal T-follicular helper cell lymphoma, follicular type peripheral T-cell lymphoma, not otherwise specified subcutaneous panniculitis-like T-cell lymphoma

As listed by the trial registrant

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

Peripheral T-cell lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    57 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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Other studies related to the condition(s) this trial covers.