Richter transformation to diffuse large B-cell lymphoma (RT-DLBCL)
Conditions
Interventions
Group 2:Group of Zanubrutinib, Tislelizumab, Obinutuzumab, Lenalidomide
Group 1:Group of Zanubrutinib, Tislelizumab, Glofitamab
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients with CLL who were confirmed by histopathology and then transformed into diffuse large B-cell lymphoma (RT-DLBCL); 2.With positive expression of CD20 and PD1 as confirmed by immunohistochemical examination; 3.Age >=18 years; 4.ECOG performance status score of 0-2; 5.Adequate organ function, such as good renal function (creatinine clearance rate >= 30 mL/min), good liver function (total bilirubin = 12 weeks; 7.Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1.Comorbidities such as uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, autoimmune diseases, severe infectious diseases, etc.; 2.Abnormal laboratory indicators during screening (unless caused by lymphoma) a) ANC < 1.5×10?9/L, PLT < 80×10?9/L b) Coagulation function: INR greater than 1.5 times the upper limit of normal; PT and APTT greater than 1.5 times the upper limit of normal c) Liver function: ALT or AST higher than 2 times the upper limit of normal, AKP and bilirubin higher than 1.5 times the upper limit of normal d) Kidney function: Creatinine higher than 1.5 times the upper limit of normal, creatinine clearance rate < 60 mL/min (estimated by Cockcroft-Gault formula); 3.Active infections requiring systemic treatment at present, such as HIV-infected individuals; 4.HBsAg positive patients need HBV DNA negative before enrollment; in addition, if the patient is HBsAg negative but HBcAb positive (regardless of the status of HBsAb), HBV DNA testing is still required. If the result is positive, antiviral treatment is needed, and HBV DNA needs to be negative before enrollment; 5.Require continuous treatment with potent and moderate CYP3A inhibitors or CYP3A inducers. If the patient has taken potent and moderate CYP3A inhibitors or CYP3A inducers within 7 days before the first administration of the study drug (or has taken these drugs for less than 5 half-lives), they cannot be enrolled; 6.Unable to swallow capsules or have diseases severely affecting gastrointestinal function, such as malabsorption syndrome, gastrectomy or small intestine resection, symptomatic inflammatory bowel disease or partial or complete intestinal obstruction; 7.Malignant tumors other than CLL that require systemic treatment (unless the treating doctor considers the malignant disease to be in a stable remission state); 8.Pregnant women and lactating women (all fertile women need a negative pregnancy test within 7 days before starting treatment); 9.Known allergies to the study drug or any excipients; 10.Other concurrent and uncontrolled medical conditions that researchers consider to affect the patient's participation in the study, including mentally ill patients or other patients known or suspected to be unable to fully comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;PFS;CRR;Safety;DOR;ORR;Until the next treatment time; | — |
Countries
China
Contacts
Public ContactWenjuan Yu
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed