NCT07058103

Tislelizumab , Cyclophosphamide, Mitoxantrone Liposomes, Chidamide, and Prednisone in the Treatment of R/R AITL

Efficacy and Safety of Tislelizumab in Combination With Cyclophosphamide, Mitoxantrone Liposomes, Chidamide, and Prednisone in the Treatment of R/R AITL: a Multicenter, Single-arm, Prospective Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The Affiliated Hospital of Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Angioimmunoblastic T cell lymphoma (AITL) is a rare and aggressive lymphoma. Some patients relapsed after initial treatment or did not respond to standard treatment (refractory). Subsequent treatment options are limited and the efficacy is not ideal. This study attempts to explore the possibility of improving the efficacy of immunotherapy combined with chemotherapy and epigenetic regulatory drugs.

Conditions

• Angioimmunoblastic T-Cell Lymphoma Recurrent
• Angioimmunoblastic T-Cell Lymphoma Refractory

Interventions

Type	Name	Description
DRUG	tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone	tislelizumab: 200mg on d1 every 3 weeks; chidamide: 20mg twice a week at least 3 days apart; cyclophosphamide: 750mg/m2 on Day 1 of each cycle, every 4 weeks; mitoxantrone liposomes: 20mg/m2 on Day 1, every 4 weeks; prednisone: 100mg/day on Day 1 to Day 5 of each course, every 4 weeks.

Timeline

• Start date: 2025-04-01
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2025-07-10
• Last updated: 2025-07-10

Locations

1 site across 1 country: China