NCT07209163

Combination Therapy With Tazemetostat in Relapsed and Refractory Peripheral T-cell Lymphoma

An Open-label, Single-arm Study Evaluating the Safety and Efficacy of Tazemetostat in Combination With Linperlisib/Golidocitinib in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (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. EZH2 inhibitor like Tazemetostat or SHR 2554 has been demonstrated its anti-tumor activity in PTCL either alone or in combination with other targeted agents. This study aims to explore the efficacy and safety of Tazemetostat in combination with Linperlisib/Golidocitinib in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma in the patients with peripheral T-cell lymphoma according to next-generation sequesing results.

Conditions

• Peripheral T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Tazemetostat	Tazemetostat 800mg, twice once daily (BID), orally
DRUG	Linperlisib	In Phase I, BOIN design will be adopted to enroll 3 to 12 participants, exploring the recommended Phase II dose (RP2D) at two dose levels of Linperlisib: 60 mg once daily (QD) and 60 mg QD, orally. In Phase II, BOP2 design will be adopted to enroll around 24 participants, aiming to evaluate the efficacy and safety of Tazemetostat with Linperlisib RP2D in patients with peripheral T-cell lymphoma with co-RHOA/TET2mut.
DRUG	Golidocitinib	In Phase I, BOIN design will be adopted to enroll 3 to 12 participants, exploring the recommended Phase II dose (RP2D) at two dose levels of Lgolidocitinib: 150 mg every other day (QOD) and 150 mg QD, orally. In Phase II, BOP2 design will be adopted to enroll around 24 participants, aiming to evaluate the efficacy and safety of Tazemetostat with Golidocitinib RP2D in patients with peripheral T-cell lymphoma without co-RHOA/TET2mut.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-03-01
• Completion: 2027-03-01
• First posted: 2025-10-06
• Last updated: 2025-10-06

Regulatory

• FDA-regulated drug study