NCT07168317

Tislelizumab , Cyclophosphamide, Mitoxantrone Liposomes, Chidamide, and Prednisone in the Treatment of New Diagnosed AITL

Efficacy and Safety of Tislelizumab in Combination With Cyclophosphamide, Mitoxantrone Liposomes, Chidamide, and Prednisone in the Treatment of New Diagnosed 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. At present, the treatment of new diagnosed AITL has limited efficacy and a high recurrence rate. The study seeks to explore the possibility of improving the efficacy of immunotherapy and chemotherapy and epigenetically regulated drugs.

Conditions

• New Diagnosed Angioimmunoblastic T-Cell Lymphoma

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: 2025-08-01
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2025-09-11
• Last updated: 2025-09-11

Locations

1 site across 1 country: China