extranodal NKT cell lymphoma
Conditions
Interventions
experimental group:PPB protocol (aspartase+PD1 antibody+bortezomib)
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study was carried out in the Affiliated Hospital of Xuzhou Medical University, Yancheng First People's Hospital and Huai 'an First People's Hospital. Criteria for inclusion 1. The initial treatment of NKT cell lymphoma of extranasal type was confirmed by pathological tissue, and the diagnostic criteria were according to WHO 2017 diagnostic criteria; 2. Age =70 years old with ECOG PS=2 points; 3. At least one two-dimensional measurable lesion was used as the evaluation basis: for intrnodal lesions, it was defined as: long diameter =1.5cm and short diameter =1.0cm; For extranodal lesions, the length and diameter should be =1.0cm; 4. Life expectancy is more than 3 months; 5. Southwest China Clinical Oncology Collaboration Group (CSWOG) stage I-II; Follow-up is available. The patients knew the characteristics of the disease and voluntarily joined the study protocol for treatment and follow-up.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria are not eligible for inclusion in this study: 1. Patients with abnormal liver and kidney function, specifically serum direct bilirubin, serum indirect bilirubin and/or glutamic-pyruvic transaminase, aspartate transaminase, and serum creatinine > 2 normal values, unless abnormal liver and kidney function is identified as associated with lymphoma; 2. Bone marrow failure, defined as absolute neutrophil count (ANC) 1104 copies /ml) and hepatitis C patients; 6. Has been diagnosed with or is undergoing treatment for a malignancy other than lymphoma, except for: ? had received treatment for the purpose of cure, and had no malignancies with known active disease for =5 years prior to enrollment; ? Well-treated basal cell carcinoma of the skin with no signs of disease (except melanoma); ? Well-treated carcinoma in situ of the cervix with no signs of disease. 7. Patients with other blood system diseases (such as hemophilia, myelofibrosis, etc.) are considered not suitable for admission; 8. Complicated with severe infection; 9. Patients who had previously received conventional chemotherapy, PD-1 or PDL-1 monoclonal antibody therapy and failed; 10. Received secondary or higher surgery within 3 weeks prior to treatment; 11. Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or the evaluation of the study results; 12. Those who were considered unsuitable for inclusion by the researchers; Known allergy to test drug ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;complete remission rate;part remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;overall survival; | — |
Countries
China
Contacts
Public ContactWei Sang
Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed