A Phase 2 interventional study of Sintilimab and Decitabine in Extranodal NK/T-cell Lymphoma, sponsored by Beijing Tongren Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-07.
Sponsored by Beijing Tongren Hospital · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with decitabine in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients
Previous study has confirmed the efficacy of anti-PD-1 antibodies (including pembrolizumab or sintilimab). However, the CR rate of PD-1 antibody monotherapy is too low. Previous studies have demonstrated that decitabine may activate the T cells and enhance the efficacy of PD-1 antibodies in Hodgkin Lymphoma. Thus, the investigators aim to evaluate the efficacy and safety of sintilimab in combination with decitabine in the treatment of NK/T cell lymphoma.
185 studies on the registry are indexed under Lymphoma, Extranodal NK-T-Cell; 33 are open to participants now.
This study's planned enrollment of 20 is below the median of 34 across 165 interventional studies indexed under Lymphoma, Extranodal NK-T-Cell.
Browse Lymphoma, Extranodal NK-T-Cell studies →Beijing Tongren Hospital is the lead sponsor of 163 studies on the registry; 53 are open to participants now.
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Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria.
Exclusion Criteria:
Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded.
Significant organ dysfunction Pregnant and lactating women. Had a history of autoimmune diseases, and disease was active in the last 6 months.
Those who were known to be allergic to drugs in the study regimen. Patients with other tumors who require surgery or chemotherapy within 6 months.
Sintilimab,200mg,ivdrip,day1 Decitabine 10mg d1-5, ivdrip, repeated every 3 weeks.
Drug: Sintilimab · Drug: Decitabine
200mg d1,ivdrip, repeated every 3 weeks
Also known as: anti-PD-1-antibody
10mg d1-5, ivdrip,repeated every 3 weeks
Also known as: hypomethylating agents
complete response rate
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Time frame: 24 weeks ±7 days
overall response rate
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 death of any reason
Time frame: up to 1year after enrollment
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sintilimab · Decitabine
Lymphoma, Extranodal NK-T-Cell →