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)

Relapsed/Refractory Peripheral T-cell Lymphoma Clinical Trial

Official title:
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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Relapsed/Refractory Peripheral T-cell Lymphoma

Clinical Trial Details

NCT number	NCT05403450
Study type	Interventional
Source	Astex Pharmaceuticals, Inc.
Contact
Status	Active, not recruiting
Phase	Phase 1/Phase 2
Start date	June 23, 2022
Completion date	December 1, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06211881` - Chi-GVM Regimen for the Treatment of R/R PTCL	N/A
Active, not recruiting	`NCT04703192` - Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)	Phase 2
Completed	`NCT05140382` - AZD4573 as Monotherapy or in Combinations With Anti-cancer Agents in Patients With r/r PTCL or r/r cHL	Phase 2
Recruiting	`NCT05182957` - Clinical Study on Anti-PD-1 Plus Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma	Phase 2