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Recruiting Phase 2 NCT07058103

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

Trial Parameters

Condition Angioimmunoblastic T-Cell Lymphoma Recurrent
Sponsor The Affiliated Hospital of Xuzhou Medical University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-04-01
Completion 2028-04-01
Interventions
tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Pathological diagnosis of AITL according to WHO classification in 2016, and pathological diagnosis of AITL according to WHO classification in 2016, and at least one evaluable or measurable lesion meeting Lugano2014 criteria: lymph node lesion, detectable lymph node length\>1.5cm; non-lymph node lesion, detectable extra-nodal lesion length\>1.0cm; * Refractory or relapsed after at least one systemic therapy (including chemotherapy, stem cell transplantation)\*; * Age ≥18 years old, male or female, ECOGPS≤3 points; * Life expectancy exceeds 3 months; * Follow-up conditions. Patients understand the characteristics of the disease and voluntarily join the study protocol for treatment and follow-up. * : Relapse: patients achieve complete response (CR) or partial response (PR), disease progression (PD) ≥6 months; refractory: treatment failure (no PR) or PD \<6 months after the last chemotherapy. Exclusion Criteria: Subjects who meet any of the following criteria are not

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