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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental | Sintilimab,200mg,ivdrip,day1 Decitabine 10mg d1-5, ivdrip, repeated every 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | 200mg d1,ivdrip, repeated every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| complete response rate | evaluated by PET-CT and MRI, according to Lugano 2014 criteria | 24 weeks ±7 days |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | evaluated by PET-CT and MRI, according to Lugano 2014 criteria | 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 |
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Inclusion Criteria:
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.
• Other experimental drugs are being used.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LIANG WANG, M.D. | Contact | +8615013009093 | wangliangtrhos@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing-wen Wang, M.D. | Beijing Tongren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Recruiting | Beijing | 100730 | China |
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| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| C000711728 | spartalizumab |
| D000077209 | Decitabine |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
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treatment with sintilimab and decitabine.
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| Decitabine | Drug | 10mg d1-5, ivdrip,repeated every 3 weeks |
|
|
| up to 1year after enrollment |
| 1-year overall survival rate | time from date of enrollment to date death of any reason | up to 1year after enrollment |
| D009369 |
| Neoplasms |
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |