primary central nervous system diffuse large B-cell lymphoma
Conditions
Interventions
single arm:sintilimab plus R-MT regimen
Sponsors
The First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diffuse large b cell lymphoma limited to the central nervous system or eyes; 2. Aged from 18 to 70 years; 3. Eastern Cancer Cooperation Group (ECOG) score 0-2; 4. Estimated time of survival more than 12 weeks; 5. The patient has at least one measurable lesion on MRI or positive CSF cytology; 6. No chemotherapy contraindications: neutrophil absolute count >= 1.5 x 10^9 / L, platelet >= 100 x 10^9 / L, ALT, AST = 50 ml / min; 7. Adequate cardiopulmonary functione; 8. The Pregnancy test of blood or urine is negative for women of reproductive potential. All patients agree to use adequate methods of contraception during the treatment period and until >= 12 months after the last chemotherapy; 9. Ability and willingness to comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Patients who have received other checkpoint inhibitors, such as PD1 monoclonal antibody, pd-l1 monoclonal antibody and CTLA4 monoclonal antibody; 2. Patients who have received radiotherapy or chemotherapy for lymphoma; 3. Tumors involve other parts of the body other than the central nervous system; 4. Previous medical history of other malignant tumors; 5. Females of childbearing age with recent family planning; 6. With active infection; 7. Suspected human immunodeficiency virus (HIV)/AIDS; 8. Difficult to control or severe cardiovascular diseases; 9. Possible allergy, allergy or intolerance to research drugs; 10. Patients with interstitial lung disease; 11. Severe diseases that may interfere with research; 12. Patients received another research drug at the same time. 13. According to the judgement of the researcher, there are other unsuitable situations for the patients to be enrolled in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?????; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Progression Free Survival;Overall Survival;Adverse events;Prognostic biomarkers; | — |
Countries
China
Contacts
Public ContactZhiyong Zeng
The First Affiliated Hospital of Fujian Medical University
Outcome results
None listed