Diffuse large B-cell lymphoma of the central nervous system
Conditions
Interventions
Experimental group:Regorafenapyr combined with autologous hematopoietic stem cell transplantation, ozantinib, and sintilimab
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age range: 18-60 years old; 2.ECOG score is 0-2 points; 3.Have not received CAR-T cell or ASCT treatment in the past; 4.Expected survival period of more than 3 months; 5.No history of malignant tumors (excluding indolent malignant tumors such as carcinoma in situ) or no active lesions in the tumor and completion of treatment>1 year; 6.Pathologically diagnosed PCNSL (lymphoma confined to the central nervous system, without involvement of other parts of the body, and with the pathological tissue type being diffuse large B-cell lymphoma or with central invasion and the pathological tissue type being diffuse large B-cell lymphoma of systemic origin); 7.Immunohistochemical marker CD19 expression is positive; 8.No contraindications for CAR-T cell and ASCT therapy; 9.During this treatment period, if other anti-tumor drugs are not used simultaneously, bisphosphonates can be used for anti bone metastasis treatment and other symptomatic treatments; 10.Can understand the situation of this study and sign an informed consent form; 11.Refractory is defined as patients who did not achieve complete remission after the first-line treatment (except for those who were intolerant to the first-line treatment): The best efficacy of the first-line treatment was PD; The best efficacy after at least 4 cycles of first-line treatment (such as 4 cycles of R-CHOP) was SD; The first-line treatment was administered for at least 6 cycles and there were residual lesions or disease progression occurred after less than 12 months of treatment.Refractory is defined as patients who did not achieve complete remission after the first-line treatment (except for those who were intolerant to the first-line treatment): The best efficacy of the first-line treatment was PD; The best efficacy after at least 4 cycles of first-line treatment (such as 4 cycles of R-CHOP) was SD; The first-line treatment was administered for at least 6 cycles and there were residual lesions or disease progression occurred after less than 12 months of treatment. 12.Recurrent is defined as a complete remission after the first-line treatment, and the recurrence occurs within < 12 months after the end of the treatment.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women; 2.Persons with any uncontrollable medical disease (including active infection, uncontrolled diabetes, severe heart disease, liver and kidney dysfunction, interstitial pneumonia, etc.); 3.Within 7 days before CD19 CAR-T cell therapy, corticosteroids (excluding dexamethasone greater than or equal to 5mg and equivalent doses of other types of corticosteroids) should be used; 4.Individuals with a history of autoimmune diseases; 5.Patients with contraindications to chemotherapy, such as those with concomitant cachexia; 6.There are uncontrolled infected patients; 7.Individuals with a history of difficult to control mental illness; 8.Researchers believe that participants who are not suitable for this experiment; 9. Obinutinib, fluoromucinide, carmustine, cimetidine, PD-1/PD-L1 monoclonal antibodies. For patients who have used more than 2 of these drugs and have developed resistance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS);Partial response(PR) and Complete response(CR);Objective response rate (ORR); | — |
Countries
China
Contacts
Public ContactZhang Mingzhi
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed