Extranodal NK / T-cell lymphoma, nasal type
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosed as ENKTL by histopathology; 2.The newly treated patients are in stage III-IV (Ann-Arbor staging system), or patients who have been relapsed and refractory after receiving any treatment for ENKTL; 3.There are evaluable lesions (CT, PET-CT or MRI evaluation, or skin lesions that can be evaluated by the naked eye); 4.Estimated survival time >= 3 months; 5.Aged 18 to 75 years; 6.The performance status (PS) is between 0-2 points of the ECOG score; 7.After the patient is enrolled in the trial, he cannot accept other drugs that may have a therapeutic effect on ENKTL; 8.White blood cell count >=3x10^9/L, neutrophil count >= 1.5x10^9/L, platelet count >= 75x10^9/L; 9.Serum creatinine = 50mL/min; 10.ALT, AST = 1.0g/L; 12.Sign informed consent.
Exclusion criteria
Exclusion criteria: 1.Existence of symptomatic CNS involvement, past or present with other malignant tumors; 2.The general condition of the patient is very poor, and the PS score is greater than 2 points; 3.Women who are pregnant or breastfeeding; 4.The patient (male or female) is likely to have children but is unwilling or fails to take effective contraceptive measures; 5.Known allergies to test drugs or any excipient components of these products; 6.Active infection (determined by the investigator); 7.According to the judgment of the investigator, there are accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study; 8.Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate;Progression-free survival at 1 year;Overall survival at 1 year;Adverse events; | — |
Countries
China
Contacts
Department of Hematology, Beijing Tongren Hospital, Capital Medical University