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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGTo 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 frame: Time forecasting: 24 months
24-month Overall Survival Rate in relapsed/refractory AITL
Proportion of patients alive at 24 months after initiation of tirelizumab combination therapy
Time frame: From first dose until death from any cause (assessed at 24 months)
24-month Progression-free Survival Rate in relapsed/refractory AITL
Proportion of patients without disease progression at 24 months per Lugano 2014 criteria
Time frame: From first dose until first documented progression or death (assessed at 24 months)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Time forecasting: 24 months
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