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

Not Applicable

Recruiting

• Conditions: Angioimmunoblastic T-Cell Lymphoma Recurrent; Angioimmunoblastic T-Cell Lymphoma Refractory
• Interventions: Drug: tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone

• Registration Number: NCT07058103
• Lead Sponsor: The Affiliated Hospital of Xuzhou Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-01
• Study First Submitted: 2025-06-10
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10
• Primary Completion: 2028-04-01
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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;

• Refractory or relapsed after at least one systemic therapy (including chemotherapy, stem cell transplantation)*;

• 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.

  • : Relapse: patients achieve complete response (CR) or partial response (PR), disease progression (PD) ≥6 months; refractory: treatment failure (no PR) or PD <6 months after the last chemotherapy.

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;
• The subject's prior history of antineoplastic therapy meets one of the following conditions: (1) prior mitoxantrone or mitoxantrone liposome therapy;(2) prior PD-1 or PD-L1 inhibitor therapy;(3) Angioimmunoblastic T-cell lymphoma previously treated with histone deacetylase inhibitors;
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with relapsed/refractory angioblastic T cell lymphoma	tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone	Patients with relapsed/refractory angioblastic T cell lymphoma

Primary Outcome Measures

Name	Time	Method
To evaluate the Objective Response Rate (Complete response+Partial response) of tirelizumab in combination with cyclophosphamide, mitoxantrone liposomes, sidaraniline, and prednisone in subjects with relapsed/refractory angioimmunoblastic T-cell lymphoma	Time forecasting: 24 months

Secondary Outcome Measures

Name	Time	Method
24-month Overall Survival Rate in relapsed/refractory AITL	From first dose until death from any cause (assessed at 24 months)	Proportion of patients alive at 24 months after initiation of tirelizumab combination therapy
24-month Progression-free Survival Rate in relapsed/refractory AITL	From first dose until first documented progression or death (assessed at 24 months)	Proportion of patients without disease progression at 24 months per Lugano 2014 criteria
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Time forecasting: 24 months

Trial Locations

Locations (1)

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China