The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with lenalidomide in the treatment of Relapsed/Refractory NK/T-cell lymphoma patients who failed pegaspargase-based regimens.
Pegaspargase is the backbone of treatment for NK/T-cell lymphoma (ENKTCL), and patients with ENKTCL who failed pegaspargase-based regimens have extremely poor survival outcomes. Previous study has confirmed the efficacy of anti-PD-1 antibodies (including pembrolizumab or sintilimab). Constitutive activation of NF-kB pathway has been demonstrated to be involved in the development of ENKTCL and plays critical role in therapy resistance. Lenalidomide, an immuno-modulatory drug, has been found to inhibit NF-kB pathway, and synergize with anti-PD-1 antibody in the treatment of multiple myeloma. Thus, we hypothesize that the combination of lenalidomide and sintilimab will further deepen the remission status and benefit patients who failed pegaspargase-based regimens.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Sintilimab, 200mg, iv day1
25mg/d oral d1-14
Beijing Tongren Hospital
Beijing, China
RECRUITINGRate of complete response
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Time frame: 24 weeks ±7 days
Rate of overall response
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Time frame: 24 weeks ±7 days
1-year progression free survival rate
time from date of enrollment to date of disease progression, death of any reason, whichever comes first
Time frame: up to 1year after enrollment
1-year overall survival rate
time from date of enrollment to date of death of any reason
Time frame: up to 1year after enrollment
safety profiles
according to CTCAE 4.0
Time frame: up to 1year after enrollment
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