Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07058103

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

Led by The Affiliated Hospital of Xuzhou Medical University · Updated on 2025-07-10

40

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathological diagnosis of angioimmunoblastic T-cell lymphoma (AITL) according to WHO 2016 criteria, with at least one measurable lesion meeting specific size criteria
  • Relapsed or refractory disease after at least one systemic therapy including chemotherapy or stem cell transplantation
  • Age 18 years or older, any gender, ECOG performance status 0 to 3
  • Life expectancy longer than 3 months
  • Willingness to understand the disease characteristics and voluntarily participate in treatment and follow-up
Not Eligible

You will not qualify if you...

  • Abnormal liver or kidney function more than twice the normal values, unless related to lymphoma
  • Bone marrow failure with low neutrophil count, platelets, or hemoglobin unless caused by lymphoma infiltration
  • Prior use of mitoxantrone or mitoxantrone liposomes, PD-1/PD-L1 inhibitors, or histone deacetylase inhibitors for AITL
  • Severe heart failure or significant heart disease within 6 months
  • Infection with AIDS, syphilis, active hepatitis B or C
  • Other uncontrolled malignancies or hematological disorders
  • History of autoimmune disease or recent use of immunosuppressive therapy above certain doses
  • Active uncontrolled infections
  • Uncontrolled hemophagocytic syndrome
  • Recent major surgery within 3 weeks
  • Participation in other drug clinical trials within 30 days
  • Pregnant or breastfeeding women or unwilling to use contraception
  • Known allergies to study drug components
  • Investigator judgment deeming patient unsuitable for enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China, 221000

Actively Recruiting

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Research Team

W

Wei Sang Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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