Diffuse large B-cell lymphoma
Conditions
Interventions
Treatment group:Selinisol, Zerbutinib, lenalidomide
Sponsors
Affiliated Hospital of Jiangnan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the visit; 2. Age =18 years; 3. According to the World Health Organization (WHO) 2016 classification criteria, DLBCL confirmed by histopathology (including primary DLBCL or DLBCL transformed from previously diagnosed indolent lymphomas such as follicular lymphoma); 4. Patients must have received 1-3 lines of systemic anti-DLBCL therapy with evidence of relapsed or refractory DLBCL, with refractory defined as failure to achieve a partial response (PR) or greater with the last treatment regimen or recurrence within 6 months after the last treatment regimen; 5. There was at least one two-dimensional measurable lesion that met Lugano 2014 lymphoma response evaluation criteria (Cheson, 2014). The longest diameter of the lymph node lesion should be >1.5 cm, and the longest diameter of the external lymph node lesion should be >1 cm. 6.ECOG score: 0-3; 7. According to the clinician's evaluation, celinisol combined with zebrutinib and lenalidomide can be accepted for treatment, and relevant laboratory tests must meet the following requirements: ? Blood routine: neutrophil absolute value (ANC)=1.0×109/L; Platelet (PLT)=75×109/L, and platelet count =50×109/L when lymphoma involved bone marrow (no platelet transfusion was performed within 7 days before testing); Hemoglobin (HGB)=8 g/dL (no blood transfusion within 14 days before testing); ? Coagulation function: International normalized ratio (INR)=1.5, partial thromboplastin time (aPTT)= 1.5 times the upper limit of normal; ? Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST)= 2.5 times of the upper limit of normal; Serum total bilirubin = 1.5 times of the upper limit of normal (Gilbert syndrome = 3 times of the upper limit of normal); ? Renal function: serum creatinine clearance (CrCl)=30 mL/min according to Cockcroft-Gault formula; 8. Men and women with reproductive potential must agree to use highly effective contraception during treatment and for 3 months after the last dose; 9. Women of childbearing age have negative serum or urine pregnancy test results at screening; 10. Patients must tolerate MRI/CT scans; 11. Expected survival is greater than 4 months.
Exclusion criteria
Exclusion criteria: 1. The patient is currently using other approved or studied antitumor agents; 2. Patients who have used celinixol, zebrutinib, or lenalidomide in the past, or are allergic to the excipients of the aforementioned therapeutic drugs or have contraindications for their use; 3. Pregnant or lactating women; 4. Cardiovascular diseases that have not been effectively controlled, including arrhythmia, congestive heart failure, hypertension, valvular disease, pericarditis, myocardial infarction, etc. 5. Active infections that have not been effectively controlled, including HIV, HBV and HCV; 6. Patients who had undergone major systemic surgery or received live vaccines or other anticancer treatments within 4 weeks before the screening, but had not recovered from side effects; 7. The patient had previously received allogeneic stem cell transplantation; 8. The patient cannot swallow voluntarily or has diseases that significantly affect gastrointestinal function, including malabsorption syndrome, gastrectomy or small bowel resection, complete intestinal obstruction, etc. 9. Ischemic or hemorrhagic cerebrovascular disease or grade =3 gastrointestinal bleeding within 6 months before screening; 10. The patient has active mental illness, alcohol, drug or substance abuse; 11. Patients who were deemed unsuitable for study enrollment by the clinician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| duration of response;progression-free survival;overall survival; | — |
Countries
china
Contacts
Public ContactHua Haiying
Affiliated Hospital of Jiangnan University
Outcome results
None listed