Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07168317

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

Led by The Affiliated Hospital of Xuzhou Medical University · Updated on 2025-09-11

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. 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

Official Title

Tislelizumab , Cyclophosphamide, Mitoxantrone Liposomes, Chidamide, and Prednisone in the Treatment of New Diagnosed 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 classification
  • At least one measurable lesion meeting Lugano 2014 criteria (lymph node >1.5 cm or extra-nodal lesion >1.0 cm)
  • No prior systemic or local treatment including chemotherapy
  • Age 18 years or older, any gender, ECOG performance status ≤3
  • Life expectancy greater than 3 months
  • Willingness and ability to follow study protocol and attend follow-up visits
Not Eligible

You will not qualify if you...

  • Abnormal liver or kidney function with bilirubin, aminotransferases, or creatinine levels over twice normal unless related to lymphoma
  • Bone marrow failure defined by low neutrophils (<1.5x10^9/L), platelets (<75x10^9/L), or hemoglobin (<90 g/L) unless caused by lymphoma
  • Previous local or systemic anti-tumor treatment
  • Chronic heart failure class III or IV, left ventricular ejection fraction below 50%, recent acute coronary syndrome, significant arrhythmias, or QT prolongation
  • Active infections including AIDS, syphilis, hepatitis B with high viral load, or hepatitis C
  • Other uncontrolled cancers or hematological disorders deemed unsuitable by investigator
  • History of autoimmune disease requiring immunosuppressive therapy or current immunosuppressive dose over 10 mg/day prednisone
  • Clinically uncontrolled active infections
  • Uncontrolled hemophagocytic syndrome
  • Recent major surgery within 3 weeks before treatment
  • Participation in other drug clinical trials within 30 days before enrollment
  • Pregnant or breastfeeding women and those unwilling to use contraception
  • Known allergies to study drugs
  • Investigator judgment of unsuitability 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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