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NOT YET RECRUITING
NCT06757387
PHASE1/PHASE2

Chidamide Plus Golidocitinib in Relapsed/Refractory Peripheral T-Cell Lymphoma

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

Summary

This is a Phase I/II, open-label, single-arm study investigating the combination of chidamide and golidocitinib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The Phase I portion utilizes a 3+3 dose-escalation design to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of the drug combination. The Phase II portion will then evaluate the efficacy and safety of the RP2D in approximately 28 patients with relapsed or refractory PTCL. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or meeting other stopping criteria. The primary goal of Phase I is to establish the safety and MTD and the RP2D. The primary goal of Phase II is to evaluate the treatment efficacy and safety of the combination at RP2D.

Official title: A Phase I/II, Open-Label, Single-Arm Study of Chidamide in Combination With Golidocitinib in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2024-12-30

Completion Date

2030-12-30

Last Updated

2025-01-03

Healthy Volunteers

No

Interventions

DRUG

chidamide and golidocitinib

Enrolled patients will receive combination therapy with golidocitinib (150 mg QD or 150 mg QOD) and chidamide (20 mg BIW or 25 mg BIW); If the MTD is determined at Dose Level 1 (chidamide 20 mg BIW / golidocitinib 150 mg QD), Dose Level 0 (chidamide 20 mg BIW / golidocitinib 150 mg QOD) will be further investigated. If the MTD is not established after escalating to Dose Level 2 (chidamide 25 mg BIW / golidocitinib 150 mg QD), the recommended Phase 2 dose (RP2D) will be determined through investigator consensus.