Natural killer/T-cell lymphoma (NKTCL) patients with relapsed/refractory disease had very poor outcome. Anti-PD-1 antibody showed promising results in response, but but the complete remission rate of was low. Some anti-PD-1 antibody based regimen showed higher and deeper response in NKTCL patients.
About 20-30% of early-stage patients and 40-60% of late-stage NKTCL patients will experience disease relapse and refractory disease, and the median survival time of relapsed patients is about 6 months. PD-1 antibody is an effective drug for the treatment of patients with relapsed/refractory NKTCL, but the response rate and complete remission rate of monotherapy are low. How to improve the prognosis of patients is an important way to try combination therapy. In this study, we aim to explore the effectiveness and safety of a novel anti-PD-1 antibody, tislelizumab, in combination with different drugs (tislelizumab plus azacytidine and lenalidomide, or tislelizumab plus etoposide and pegaspargase) to treat refractory NK/T.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
tislelizumab, 200mg, iv, day 1, every 21 days. azacytidine, 75mg/m2, ih, days 1-7, every 21 days. lenalidomide, 25mg, po, days 1-14, every 21 days.
tislelizumab, 200mg, iv, day 1, every 21 days. etoposide, 100mg, iv, days 1-3, every 21 days. pegaspargase, 2000U/m2, day 1, every 21 days
Xinhua Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Overall response rate
The overall response rate will be assessed on Week 12
Time frame: Week 12 +/-7 days
Complete response rate
The complete response rate will be assessed on Week 12
Time frame: Week 12 +/-7 days
Progression free survival
Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.
Time frame: 1-year
Overall survival
Overall survival is defined as the time from entry onto the treatment until death of any reason
Time frame: 1-year
Treatment-Related Adverse Events as Assessed by CTCAE v5.0
From day 1 of each course of chemotherapy to the 3 months after the last dose of therapy
Time frame: Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v5.0.
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