Diffuse Large B-cell Lymphoma
Conditions
Interventions
Experimental group:Polatuzumab vedotin, Zanubrutinib, Lenalidomide and Rituximab (Pola-ZR2)
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically-confirmed diffuse large B-cell lymphoma (without central nervous system involvement). 2. Aged >= 80 years old or aged 70-79 with comprehensive geriatric assessment stratified as unfit or frail. 3. International prognostic index score 2 to 5. 4. At least 1 measurable site of disease (defined as lymph nodes with the long diameters longer than 1.5cm, or extra-nodal sites with the long diameters longer than 1.0cm; meanwhile, any lesion site with at least 2 measurable vertical diameters). 5. Able to swallow capsules. 6. Life expectancy of at least 3 months determined by researchers. 7. The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research. 8. Anti-lymphoma drugs have not been used before (except glucocorticoids).
Exclusion criteria
Exclusion criteria: 1. Uncontrolled blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases. 2. Laboratory measures meet the following criteria at screening (unless caused by lymphoma): a) Neutrophils470ms (females) or 480ms (males), type 2 second-degree atrioventricular block or third-degree atrioventricular block. 4. Patients with HbsAg positive are required to have HBV DNA<1.0×10^3 IU/ml before entering the group. In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA test is also required, and HBV DNA<1.0×10^3 IU/ml is required before entering the group. 5. Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol. 6. HIV-infected patients. 7. History of stroke or intracranial hemorrhage within 6 months prior to start of therapy. 8. Other medical conditions determined by the researchers that may affect the study
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate at the end of induction treatment;2-year Progression-free Survival (PFS) Rate;2-year Overall Survival (OS) Rate;Safety; | — |
Primary
| Measure | Time frame |
|---|---|
| Complete response rate at the end of induction treatment; | — |
Countries
China
Contacts
Public ContactZhao Weili
Shanghai Institute of Hematology; Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed