Tislelizumab with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone for newly diagnosed AITL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, single-center interventional study giving a combination of tislelizumab, cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone to adults with newly diagnosed angioimmunoblastic T‑cell lymphoma (AITL). Eligible patients are treatment-naïve, have a pathological diagnosis of AITL, at least one measurable lesion per Lugano2014 criteria, and ECOG performance status ≤3. The regimen pairs PD‑1 blockade with a chemotherapy backbone and an oral HDAC inhibitor, with planned monitoring for tumor response, safety, and recurrence over scheduled visits. Results will focus on response rates, progression-free survival, and tolerability to determine whether the combination merits further study.

Why it matters

Who can join: the full rules

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;

  * Never received systemic or local treatment including chemotherapy before;
  * 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.

Exclusion Criteria:

* Subjects who meet any of the following criteria are not eligible for inclusion in this study:

  * Patients with abnormal liver and kidney function, specifically serum direct bilirubin, serum indirect bilirubin and/or alanine aminotransferase, aspartate aminotransferase and serum creatinine\>2 times normal values, unless abnormal liver and kidney function is considered to be related to lymphoma;
  * Bone marrow failure, specifically defined as absolute neutrophil count (ANC)\<1.5\*10\^9/L or platelets \<75\*10\^9/L or Hb\<90g/L, unless changes in hemogram are considered to be associated with lymphoma infiltration of the bone marrow;
  * Patients who have previously received local or systemic anti-tumor treatment;
  * Chronic heart failure with cardiac function class III or IV; or left ventricular ejection fraction \<50%; or patients with the following cardiac diseases within 6 months: acute coronary syndrome; acute heart failure (Class III or IV of cardiac function class); patients with a history of clinically significant QT prolongation (\>450 ms for men,\>470 ms for women), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, symptomatic coronary heart disease requiring medical treatment;
  * AIDS, syphilis, active B (HBV DNA\>1\*10\^4 copies/ml) and hepatitis C;
  * Patients with other malignancies that are not effectively controlled; or with other hematological disorders (e.g. hemophilia, myelofibrosis, etc.), the investigator considers that the patient is not suitable for enrollment;
  * History of autoimmune disease, receiving immunosuppressive therapy before enrollment, immunosuppressive dose\>10 mg/day or oral prednisone for more than 2 weeks;
  * Clinically uncontrolled active infection (including bacterial, fungal or viral infections), and drug therapy is ineffective;
  * Patients with uncontrolled hemophagocytic syndrome;
  * Patients who have received secondary surgery or above within 3 weeks before treatment;
  * Patients who have participated in clinical trials of other drugs within 30 days before enrollment or are participating in clinical trials of other new drugs;
  * Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
  * Known allergies to investigational drug components;
  * The investigator considers that the enrollment is not suitable.

Where it's running

• The Affiliated Hospital of Xuzhou Medical University
  Xuzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Wei Sang Doctor
• Email: sw1981726@126.com
• Phone: 136452076

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.