Diffuse large B-cell lymphoma
Conditions
Interventions
Experimental group:BTK inhibitor combined with sidabenamine
Sponsors
Shanghai Tongji Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Patients with relapsed and refractory diffuse large B-cell lymphoma meeting the following criteria: I non-GCB diffuse large B-cell lymphoma confirmed by immunohistochemistry or DNA microarray; IISecond, after at least two previous chemotherapy regimens (excluding monotherapy rituximab), CAR-T cell therapy was also counted as one treatment regimen; ? The interval between the last chemotherapy and disease progression should not be less than 14 days; ? Conditions not suitable for hematopoietic stem cell transplantation or giving up hematopoietic stem cell transplantation due to conditions limitation. 2) Age =18 years old; 3) The estimated survival time is 6 months to 2 years; 4) ECOG score =2; 5)Adequate reserve of organ function: (1) alanine aminotransferase, aspartate aminotransferase = 2.5× UNL (upper limit of normal value); (2) Creatinine clearance (Cockcroft-Gault method) = 60 mL/min; (3) serum total bilirubin and alkaline phosphatase =1.5× UNL; (4) Glomerular filtration rate> 50ml/min (5) Cardiac ejection fraction (EF) = 45%; (6) In the indoor natural air environment, the basal oxygen saturation > 92% (7) Blood routine: absolute number of neutrophils> 1000/mm3, platelet number 45×10^9/L, hemoglobin 80g/L; 6) Women of childbearing age who had a negative urine pregnancy test before the start of drug administration and agreed to take effective contraceptive measures during the trial period until the last follow-up; 7) Participants who voluntarily participated in the study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: Patients who met any of the following exclusion criteria were not eligible for the trial: 1) With a history of epilepsy or other central nervous system diseases; 2) Patients with graft-versus-host response requiring immunosuppressive therapy; 3) Patients with prolonged QT or severe heart disease in the past; 4) Pregnant or lactating women; 5) Uncured active infected persons; 6) People with active hepatitis B or C virus infection; 7) Severe infections that are not under control; 8) Those who have used any gene therapy product (except those who have received CAR-T cell therapy); 9) Creatinine >2.5mg /dl, ALT /AST>3 times the normal amount or bilirubin >2.0 mg /dl; 10) Those who have other uncontrolled diseases and are not considered suitable for enrollment by the researcher; 11) People living with HIV; 12) Patients who are allergic to BTK inhibitors and any component of sidabenamine; 13) Any situation that the investigator believes may increase the risk to the subject or interfere with the results of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;Duration of remmission;Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Countries
china
Contacts
Public Contactaibin liang
Shanghai Tongji Hospital
Outcome results
None listed