NCT07081607

Golidocitinib With Azacitidine and Chidamide in Patients With Peripheral T-cell Lymphoma.

An Open-label, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib Combined With Azacitidine and Chidamide in Patients With Peripheral T-cell Lymphoma.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In decades, the outcome of patients with peripherial T-cell lymphomas is dismal, especially in relapsed or refractory population. After failure to the frontline treatment, patients have limited treatment options and elderly population usually have no chance to undergo transplantation due to age or comorbidity, etc. Golidocitinib and chidamide were approved in treating r/r PTCL in China, while azacytidine has been demonstrated its anti-tumor activity in PTCL as well. This study aims to explore the efficacy and safety of golidocitinib combined with azacytidine and chidamide in the patients with peripheral T-cell lymphoma who are eligible for intensive chemotherapy or transplantation.

Conditions

• Peripheral T-Cell Lymphoma, Not Classified

Interventions

Type	Name	Description
DRUG	golidocitinib with azacytidine and chidamide	In Phase I, a "3+3" dose-escalation design will be adopted to enroll 3 to 12 participants, exploring the recommended Phase II dose (RP2D) at two dose levels of golidocitinib: 150 mg every other day (QOD) and 150 mg once daily (QD). In Phase II, we aim to evaluate the efficacy and safety of golidocitinib RP2D po in combination with chidamide 20mg biw po and azacytidine 100mg d1-7, SC in patients with peripheral T-cell lymphoma

Timeline

• Start date: 2025-07-15
• Primary completion: 2026-07-16
• Completion: 2028-07-16
• First posted: 2025-07-23
• Last updated: 2025-07-23