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

NCT ID: NCT07168317

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2028-08-01

Brief Summary

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

New Diagnosed Angioimmunoblastic T-Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with new diagnosed angioblastic T cell lymphoma

Patients with new diagnosed angioblastic T cell lymphoma

Group Type: EXPERIMENTAL

tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone

Intervention Type: DRUG

tislelizumab: 200mg on d1 every 3 weeks; chidamide: 20mg twice a week at least 3 days apart; cyclophosphamide: 750mg/m2 on Day 1 of each cycle, every 4 weeks; mitoxantrone liposomes: 20mg/m2 on Day 1, every 4 weeks; prednisone: 100mg/day on Day 1 to Day 5 of each course, every 4 weeks.

Interventions

tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone

tislelizumab: 200mg on d1 every 3 weeks; chidamide: 20mg twice a week at least 3 days apart; cyclophosphamide: 750mg/m2 on Day 1 of each cycle, every 4 weeks; mitoxantrone liposomes: 20mg/m2 on Day 1, every 4 weeks; prednisone: 100mg/day on Day 1 to Day 5 of each course, every 4 weeks.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Sang Doctor

Role: CONTACT

sw1981726@126.com

136452076

Facility Contacts

Wei Sang Doctor

Role: primary

sw1981726@126.com

136452076

Other Identifiers

XYFY2025-KL332-01

Identifier Type: -

Identifier Source: org_study_id