Diffuse large B-cell lymphoma
Conditions
Interventions
R-GDP+zanbrutinib group:zanbrutinib
Sponsors
Affiliated Hospital of Jining Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Histopathologically confirmed diffuse large B-cell lymphoma (DLBCL, non-GCB); 2. Known expression levels of MYC, BCL-2 and BCL-6 (detected by immunohistochemical methods, qualitative or quantitative detection. Note: whether it belongs to MYC, BCL-2 and BCL-6 double expression or triple expression patients, can be included); 3. Patients with no remission or first relapse after remission after first-line treatment regimens (including immunochemotherapy, chemotherapy or hematopoietic stem cell transplantation) (that is, this trial regimen is used as a second-line salvage regimen); 4. Have at least one assessable lesion; 5. 18~65 years old, gender is not limited; ECOG physical fitness score is 0-2 points; 6. For patients with non-bone marrow invasion, the absolute value of neutrophils is >=1.5x10^9/L, and the platelet count is >=100x10^9/L (the platelet count is determined by the investigator according to the condition, and the minimum can be >=75x10^9/L). L), hemoglobin >= 90g/L; 7. The level of organ function meets the following requirements: renal function needs to meet: creatinine =50%, asymptomatic arrhythmia; 8. Expected survival time >= 3 months; 9. Have not received radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation within 4 weeks before the drug; 10. Fully understand and inform about this study and sign the written informed consent before the trial screening.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women and patients of reproductive age who do not want to take contraceptive measures; 2. Patients with a history of clinically significant prolonged QTC (male > 450ms, female > 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, onset of myocardial infarction (MI) within 1 year, congestive heart failure (CHF), and symptomatic coronary heart disease requiring medical treatment; 3. Patients with end-diastolic pericardial fluid dark area width >=10mm shown by B-ultrasound; 4. Organ transplant recipients; 5. Patients who received symptomatic treatment for pre-myelotoxicity within 7 days before enrollment; 6. Patients with active bleeding; 7. Patients with thrombosis, embolism, cerebral hemorrhage, cerebral infarction and other diseases or medical history; 8. Patients with active infection or persistent fever within 14 days before enrollment; 9. HBV, HCV and HIV active infection; 10. Less than 6 weeks after major organ surgery; 11. Abnormal liver function (total bilirubin > 1.5 times the normal value, ALT/AST > 2.5 times the normal value or liver invasion ALT/AST > 5 times normal value), abnormal renal function (serum creatinine > 1.5 times normal value); 12. Persons with mental disabilities/unable to obtain informed consent; 13. Patients with drug abuse or long-term alcohol abuse that may affect the evaluation of test results; 14. Patients with lymphoma invasion of central nervous system; 15. The investigator decided that he was not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation;therapeutic effective evaluation;objective response rate, ORR;adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone marrow involvement;flow cytometry; | — |
Countries
China
Contacts
Public ContactZhang Hao
Affiliated Hospital of Jining Medical University
Outcome results
None listed