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.
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;
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;
Single group
tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone
Drugtislelizumab: 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.
Outcome Measure
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
24-month Overall Survival Rate in relapsed/refractory AITL
Proportion of patients alive at 24 months after initiation of tirelizumab combination therapy
24-month Progression-free Survival Rate in relapsed/refractory AITL
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
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