A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL)
NCT ID: NCT05403450
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
33 participants
INTERVENTIONAL
2022-06-23
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phases 1 and 2: Tolinapant + Oral Decitabine/Cedazuridine
Tolinapant, orally, once daily (QD) on Days 1 to 7 and 15 to 21 of each 28-day cycle in combination with oral decitabine/cedazuridine fixed-dose combination (FDC) tablet, QD on days determined by the Lead-in Phase during each 28-day cycle. The starting dose of tolinapant will be escalated stepwise in successive cohorts until the RP2D is determined.
Based on RP2D and results determined from Phase 1 participants would receive tolinapant at the identified RP2D in combination with decitabine/cedazuridine, FDC tablet, orally, QD on days determined by the Lead-in Phase during each 28-day cycle in Phase 2.
Tolinapant
Capsule for oral administration
Decitabine + Cedazuridine
Tablet for oral administration
Phase 1: Oral Decitabine/Cedazuridine
Decitabine/cedazuridine FDC tablet, orally, QD on days determined by the Lead-in Phase during each 28-day cycle.
Decitabine + Cedazuridine
Tablet for oral administration
Interventions
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Tolinapant
Capsule for oral administration
Decitabine + Cedazuridine
Tablet for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Taiho Oncology, Inc.
INDUSTRY
Responsible Party
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Locations
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City of Hope Site #151
Duarte, California, United States
University of Califonia, Los Angeles
Los Angeles, California, United States
Stanford University
Stanford, California, United States
University of Colorado Anschutz Medical Campus Site #118
Aurora, Colorado, United States
Yale Cancer Center Site #109
New Haven, Connecticut, United States
Moffitt Cancer Center Site #157
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute Site#159
Detroit, Michigan, United States
Rochester Skin Lymphoma Medical Group, PLLC Site #147
Fairport, New York, United States
NYU Langone Laura and Isaac Perlmutter Cancer Center Site #153
New York, New York, United States
University of Pennsylvania Site# 160
Philadelphia, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center Site #101
Houston, Texas, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Concord Hospital
Concord, New South Wales, Australia
Monash Medical Center
Melbourne, Victoria, Australia
Linear Clinical Research Site #834
Nedlands, , Australia
Hôpital Bretonneau
Tours, Indre-et-Loire, France
Centre Henri Becquerel
Rouen, Seine-Maritime, France
Institut Bergonié Site#553
Bordeaux, , France
Institut Paoli-Calmettes
Marseille, , France
CHU Saint-Eloi Site#556
Montpellier, , France
Centre Antoine Lacassagne
Nice, , France
AP-HP Pitie Saltpetriere Site# 552
Paris, , France
Institut Gustave Roussy
Villejuif, , France
Ospedale Santa Maria delle Croci di Ravenna
Ravenna, Emilia-Romagna, Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
Meldola, Forli-Cesena, Italy
U.O.C. di Ematologia Pad. 8IRCCS Azienda OspedalieroUniversitaria di Bologna Site#651
Bologna, , Italy
Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia Site#650
Brescia, , Italy
Istituto Europeo di Oncologia Site#652
Milan, , Italy
Fondazione IRCCS San Gerardo dei Tintori Site #655
Monza, , Italy
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, Masovia, Poland
Ośrodek Badań Klinicznych Wczesnych Faz - Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk, Pomeranian Voivodeship, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Lodz, Łódź Voivodeship, Poland
Hospital Universitario Virgen del Rocío
Seville, Andalusia, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
Barcelona, Catalonia, Spain
Hospital del Mar Site #704
Barcelona, , Spain
Hospital Universitario Fundación Jiménez Díaz Site #703
Madrid, , Spain
Hospital Universitario 12 de Octubre Site#710
Madrid, , Spain
Hospital Universitario Marqués de Valdecilla Site#711
Santander, , Spain
Guy's and Saint Thomas' NHS Foundation Trust
London, England, United Kingdom
University College London Hospitals NHS Foundation Trust
London, England, United Kingdom
The Christie NHS Foundation Trust
Manchester, England, United Kingdom
Countries
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Other Identifiers
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2021-005338-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ASTX660-03
Identifier Type: -
Identifier Source: org_study_id
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