Extranodal NK/T cell lymphoma
Conditions
Interventions
Experimental group:Tislelizumab+Chidamide
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed extranodal NK/T cell lymphoma by histopathology. 2. Aged >=70 years, or >=60 years and ECOG>2 points. 3. The ECOG score is 0-3, and the estimated survival time is more than 3 months. 4. Having adequate organ and bone marrow function, as defined below: (1) Blood routine: absolute neutrophil count (ANC) >= 1.0x10^9/L, platelet count (PLT) >= 50x10^9/L, hemoglobin (HGB) >= 7.0 g /dL. (2) Liver function: serum total bilirubin (TBIL) <= 2 x upper limit of normal value (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3xULN. (3) Renal function: serum creatinine (Cr) <= 2xULN. 5. Be able to understand and be willing to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Have received systemic chemotherapy; 2. History of peripheral neuropathy; 3. HIV positive; 4. There is a disease of the central nervous system; 5. Have used HDAC inhibitor or PD1 antibody; 6. There are contraindications to the drugs in the program; 7. Participate in another interventional clinical study at the same time, unless participating in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study; 8. Receive a live attenuated vaccine within 4 weeks before the first dose of study treatment or plan to receive it during the study; 9. Received major surgical operations (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures within 4 weeks before the first dose of study treatment; 10. Active, known or suspected autoimmune disease or history of the disease within the past 2 years (Vitiligo, psoriasis, alopecia or Grave's disease not requiring systemic treatment within the past 2 years, hypothyroidism requiring only thyroid hormone replacement therapy, and type I diabetes requiring only insulin replacement therapy can be enrolled) ; 11. History of suppression of primary immunodeficiency; 12. Patients who are pregnant or breastfeeding; 13. Patients who are judged by the investigator to be unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactFan Lei
Jiangsu Province Hospital
Outcome results
None listed