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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) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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)

A Phase 1-2, Open-Label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Subjects With Relapsed/Refractory Peripheral T-cell Lymphoma

NCT05403450•Taiho Oncology, Inc.

View on ClinicalTrials.gov

Summary

The primary purpose of the study is to assess safety, and to identify the recommended phase 2 dose (RP2D) of tolinapant in combination with oral decitabine/cedazuridine in Phase 1 and to assess preliminary efficacy as determined by overall response rate (ORR) in Phase 2. As no safe and tolerable dosing for the combination of tolinapant and decitabine/cedazuridine was identified based on protocol defined criteria, Sponsor decided to halt recruitment and to not conduct Phase 2 of the study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+8 more criteria

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.
+22 more criteria

Locations (46)

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

Key Dates

Start Date

February 22, 2023

Primary Completion Date

December 16, 2024

Completion Date

March 31, 2026

Last Updated

February 23, 2026

Enrollment

ACTUAL participants

Conditions

Relapsed/Refractory Peripheral T-cell Lymphoma

Interventions

Tolinapant

DRUG

Decitabine + Cedazuridine

DRUG

Study to Evaluate Efficacy and Safety of HH2853 in Relapsed/Refractory Peripheral T-cell Lymphoma

NCT06909877

Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL)

View study

RECRUITINGPHASE1/PHASE2

A Phase I/II Study of Golidocitinib Combined with Pomalidomide in R/R PTCL

NCT06855823

Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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