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Promising lymphoma combo trial halted over safety issues

NCT ID NCT05403450

Disease control Sponsor: Taiho Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tested a new drug combination (tolinapant plus decitabine/cedazuridine) in 33 adults with a rare, hard-to-treat blood cancer called peripheral T-cell lymphoma that had returned or not responded to prior treatment. The goal was to find a safe dose and see if the combination could shrink tumors. However, the trial was stopped early because the combination was not safe enough at any dose tested, so the second phase was not conducted.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

33 people

The number who actually took part.

Started

Feb 2023

Finished

Jul 2026

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. Participants with expected life expectancy of \>12 weeks. 2. Participants must have histologically confirmed R/R PTCL (local pathology report) as defined by 2016 World Health Organization (WHO) classification. The following subtypes are eligible for the study: 1. Extranodal natural killer (NK)/T-cell lymphoma nasal type. 2. Enteropathy-associated T-cell lymphoma. 3. Monomorphic epitheliotropic intestinal T-cell lymphoma. 4. Hepatosplenic T-cell lymphoma. 5. Subcutaneous panniculitis-like T-cell lymphoma. 6. Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS). 7. Angioimmunoblastic T-cell lymphoma. 8. Follicular peripheral T-cell lymphoma. 9. Nodal peripheral T-cell with T-follicular helper (THF) phenotype. 10. Anaplastic large-cell lymphoma (ALCL). 3. Participants must have evidence of progressive disease and must have received at least two prior systemic therapies. 4. Participants must have measurable disease by contrast-enhanced diagnostic CT (at least 1 nodal lesion \>1.5 centimeters (cm) or extranodal lesions \>1.0 cm). 5. Participants with CD30-positive disease must have received, be ineligible for, or intolerant to brentuximab vedotin. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 7. Acceptable organ function as per protocol. 8. Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group \[CTFG\]) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Exclusion Criteria: 1. Prior treatment with tolinapant or any hypomethylating agent. 2. Hypersensitivity to tolinapant or oral decitabine/cedazuridine, excipients of the drug product, or other components of the study treatment regimen. 3. Poor medical risk because of systemic diseases (e.g., uncontrolled infections) in addition to the qualifying disease under study. 4. Life-threatening illness, significant organ system dysfunction, or other condition that, in the investigator's opinion, could compromise participant safety or the integrity of the study outcomes, or interfere with the absorption or metabolism of tolinapant. 5. A history of, or at risk for, cardiac disease, as evidenced by 1 or more of the following conditions: 1. Abnormal left ventricular ejection fraction. 2. Congestive cardiac failure of Grade ≥3. 3. Unstable cardiac disease. 4. History or presence of complete left bundle branch block, third-degree heart block, cardiac pacemaker, or clinically significant arrhythmia. 5. History of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy. 6. Screening 12-lead electrocardiogram (ECG) with measurable QTc interval of ≥470 milliseconds (msec) (according to either Fridericia's or Bazett's correction). 7. Any other condition that, in the opinion of the investigator, could put the participant at increased cardiac risk. 6. Known history of human immunodeficiency virus (HIV) infection; or seropositive results consistent with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. 7. Grade 3 or greater neuropathy. 8. Known significant mental illness or other conditions such as active alcohol or other substance abuse that, in the opinion of the investigator, predisposes the participant to high risk of noncompliance with the protocol treatment or assessments. 9. Prior anticancer treatments or therapies within the indicated time window before first dose of study treatment (tolinapant), as follows: 1. Cytotoxic chemotherapy or radiotherapy within 4 weeks prior. 2. Monoclonal antibodies within 4 weeks prior. 3. At least 12 weeks must have elapsed since chimeric antigen receptor T-cell (CAR-T) infusion. 4. Small molecules or biologics (investigational or approved) within the longer of 3 weeks or 5 half-lives before study treatment. 10. Monoclonal antibody treatment for rheumatologic conditions within 4 weeks of study drug initiation. 11. Concurrent second malignancy currently requiring active therapy, except breast or prostate cancer stable on or responding to endocrine therapy or superficial bladder cancer. 12. Any concurrent second malignancy that is metastatic. 13. Known central nervous system (CNS) lymphoma. 14. Participants with a history of allogeneic transplant are excluded from this study. 15. Autotransplant within 100 days of the first dose of the study drug(s). 16. Systemic corticosteroids \>10 mg prednisone equivalent within 7 days of the first dose of study drug(s). 17. Anti-T-cell directed therapy: 1. Lymphotoxic agents (e.g., anti-CD52) in the past 12 months. 2. Inhibitory drugs (e.g., calcineurin inhibitors) within 4 weeks of the first dose of study drug(s). 18. Use of a concomitant medication which is a moderate or strong CYP3A4 inhibitor/inducer within 2 weeks of the start of the study. 19. Use of any vaccine within 10 days of the first dose of the study drug(s).

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Conditions

The condition(s) this trial relates to.

mature T-cell and NK-cell non-Hodgkin lymphoma non-Hodgkin lymphoma

As listed by the trial registrant

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

Relapsed/refractory peripheral T-cell lymphoma

Contacts and locations

Locations

  • AP-HP Pitie Saltpetriere Site# 552

    Paris, 75013, France

  • Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia Site#650

    Brescia, 25123, Italy

  • Barbara Ann Karmanos Cancer Institute Site#159

    Detroit, Michigan, 48201, United States

  • CHU Saint-Eloi Site#556

    Montpellier, 34295, France

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Henri Becquerel

    Rouen, Seine-Maritime, 76038, France

  • City of Hope Site #151

    Duarte, California, 91010, United States

  • Concord Hospital

    Concord, New South Wales, 2139, Australia

  • Fondazione IRCCS San Gerardo dei Tintori Site #655

    Monza, 20900, Italy

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Guy's and Saint Thomas' NHS Foundation Trust

    London, England, SE1 9Rt, United Kingdom

  • Hospital Universitario 12 de Octubre Site#710

    Madrid, 28041, Spain

  • Hospital Universitario Fundación Jiménez Díaz Site #703

    Madrid, 28040, Spain

  • Hospital Universitario Marqués de Valdecilla Site#711

    Santander, 39008, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, Andalusia, 41013, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 8025, Spain

  • Hospital del Mar Site #704

    Barcelona, 08003, Spain

  • Hôpital Bretonneau

    Tours, Indre-et-Loire, 37000, France

  • Institut Bergonié Site#553

    Bordeaux, 33000, France

  • Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

    Barcelona, Catalonia, 8908, Spain

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institut Paoli-Calmettes

    Marseille, 13009, France

  • Istituto Europeo di Oncologia Site#652

    Milan, 20141, Italy

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST

    Meldola, Forli-Cesena, 47014, Italy

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Linear Clinical Research Site #834

    Nedlands, 6009, Australia

  • Moffitt Cancer Center Site #157

    Tampa, Florida, 33612, United States

  • Monash Medical Center

    Melbourne, Victoria, 3168, Australia

  • NYU Langone Laura and Isaac Perlmutter Cancer Center Site #153

    New York, New York, 10016, United States

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

    Warsaw, Masovia, 02-781, Poland

  • Ospedale Santa Maria delle Croci di Ravenna

    Ravenna, Emilia-Romagna, 48121, Italy

  • Ośrodek Badań Klinicznych Wczesnych Faz - Uniwersyteckie Centrum Kliniczne w Gdańsku

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Rochester Skin Lymphoma Medical Group, PLLC Site #147

    Fairport, New York, 14450, United States

  • Stanford University

    Stanford, California, 94305, United States

  • The Christie NHS Foundation Trust

    Manchester, England, M20 4BX, United Kingdom

  • The University of Texas MD Anderson Cancer Center Site #101

    Houston, Texas, 77030, United States

  • U.O.C. di Ematologia Pad. 8IRCCS Azienda OspedalieroUniversitaria di Bologna Site#651

    Bologna, 40138, Italy

  • University College London Hospitals NHS Foundation Trust

    London, England, W1T 7HA, United Kingdom

  • University of Califonia, Los Angeles

    Los Angeles, California, 90095, United States

  • University of Colorado Anschutz Medical Campus Site #118

    Aurora, Colorado, 80045, United States

  • University of Michigan Rogel Cancer Center

    Ann Harbor, Michigan, 48109, United States

  • University of Pennsylvania Site# 160

    Philadelphia, Pennsylvania, 19104, United States

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia, 22908, United States

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322, United States

  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

    Lodz, Łódź Voivodeship, 93-513, Poland

  • Yale Cancer Center Site #109

    New Haven, Connecticut, 06511, United States

More trials for these conditions

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