RecruitingPhase 2NCT07058103

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


Sponsor

The Affiliated Hospital of Xuzhou Medical University

Enrollment

40 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of five drugs — tislelizumab (an immunotherapy), cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone — for people with a rare type of T-cell lymphoma called angioimmunoblastic T-cell lymphoma (AITL) that has come back or stopped responding to prior treatment. **You may be eligible if...** - You have been diagnosed with AITL (a specific type of T-cell lymphoma) confirmed by a tissue biopsy - Your lymphoma has returned or is no longer responding to prior treatment - You have at least one measurable tumor that can be tracked on scans - You are in good enough health to receive treatment - You are 18 years of age or older **You may NOT be eligible if...** - You have never been treated for AITL before (this study is for relapsed/refractory cases) - You have active autoimmune disease requiring treatment - You have serious heart, liver, or kidney problems - You have active infections (including HIV or hepatitis B/C) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGtislelizumab 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.


Locations(1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

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NCT07058103