RecruitingPhase 2NCT07168317

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


Sponsor

The Affiliated Hospital of Xuzhou Medical University

Enrollment

40 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a five-drug combination (tislelizumab, cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone) for newly diagnosed angioimmunoblastic T-cell lymphoma (AITL) — a rare and aggressive type of lymphoma that affects the immune system. These drugs work together through different mechanisms to attack the cancer. **You may be eligible if...** - You have been newly diagnosed with AITL confirmed by biopsy - You have at least one measurable lesion on imaging - You have not received any prior chemotherapy or systemic cancer treatment - You are 18 years or older - Your general health is sufficient to tolerate treatment (ECOG ≤3) - You are expected to live more than 3 months **You may NOT be eligible if...** - You have previously received any systemic treatment for this lymphoma - You have active serious infections or autoimmune conditions - You have severe heart, liver, or kidney disease - 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.

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07168317