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

This treatment tests whether adding the immunotherapy tislelizumab to chemotherapy (cyclophosphamide and mitoxantrone liposomes), the epigenetic drug chidamide, and prednisone helps adults newly diagnosed with angioimmunoblastic T‑cell lymphoma.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Affiliated Hospital of Xuzhou Medical University (other)
• Drugs / interventions: chemotherapy, prednisone, immunotherapy
• Locations: 1 site (Xuzhou, Jiangsu)
• Trial ID: NCT07168317 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with a confirmed, newly diagnosed AITL who have not received prior systemic or local therapy, have at least one measurable lesion, ECOG ≤3, and life expectancy over three months.

Not a fit: Patients with significant liver or kidney dysfunction, prior systemic treatment for AITL, or without measurable disease are unlikely to be eligible and may not benefit from this regimen.

Why it matters

Potential benefit: If successful, this combination could increase response rates and reduce recurrence compared with current first-line options for AITL.

How similar studies have performed: Components like chidamide and PD‑1 inhibitors have shown activity in peripheral T‑cell lymphomas, but combining tislelizumab with this specific chemotherapy and chidamide backbone in newly diagnosed AITL is relatively novel and not yet proven.

Eligibility criteria

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 this trial is running

Xuzhou, Jiangsu

• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Wei Sang Doctor

Conditions: New Diagnosed Angioimmunoblastic T-Cell Lymphoma