The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with Pegaspargase and anlotinib in the treatment of stage IV NK/T-cell lymphoma patients unfit for high-dose chemotherapy.
Stage IV NK/T-cell lymphoma has a poor prognosis, and autologous hematopoietic stem cell transplantation can improve the prognosis of patients who have achieved remission after chemotherapy. The median survival time for patients who were not suitable for transplantation was about 1 year. Asparaginase is the backbone drug for the treatment of NK/T-cell lymphoma. PD-1 antibody is effective for relapsed/refractory NK/T-cell lymphoma. Our previous study found that anlotinib is active in relapsed/refractory NK/T Cell lymphoma. This study is aimed to investigate the efficacy and safety of Sintilimab, a PD-1 antibody approved in China, in combination with Pegaspargase and anlotinib in the treatment of stage IV NK/T-cell lymphoma patients unfit for high-dose chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Patients will be given LEAP regimen every 3 weeks for 8 cycles.
Xinhua Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGComplete response rate
The complete response rate will be assessed on week 24.
Time frame: Week 24 +/-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 response rate
The overall response rate will be assessed on Week 24
Time frame: Week 24 +/-7 days
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.
Time frame: Day 1 of each course of chemotherapy and then every 3 months for 1 year
Overall survival
Overall survival is defiend as the time from entry onto the treatment until death of any reason
Time frame: 1-year
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