Diffuse Large B-Cell Lymphoma
Conditions
Interventions
ZR Program Group:Administer treatment with the ZR regimen (Zanubrutinib plus Rituximab)
R-mini-CHOP Program Group:Administer treatment with the R-mini-CHOP regimen (rituximab, cyclophosphamide, doxorubicin/epirubicin/liposomal doxorubicin, vincristine, and prednisone)
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
16 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1) Primary diffuse large B-cell lymphoma diagnosed independently as CD20-positive by 2 pathologists; 2) Elderly patients >= 80 years of age or who underwent a CGA assessment (IACA index) with an IACA score of >= 3 (see Table 1); 3) Tumor tissue second-generation sequencing consistent with an MCD phenotype; 4) Anticipated survival of more than 6 months.
Exclusion criteria
Exclusion criteria: 1) Previous history of hematologic or non-hematologic neoplasms treated with radiotherapy; 2) Uncontrolled severe infections or autoimmune diseases; 3) Abnormal liver and kidney function at baseline (alanine aminotransferase or aspartate aminotransferase levels exceeding 2 times the upper limit of normal [ULN], alkaline phosphatase or bilirubin levels exceeding 1.5 times the ULN, and creatinine levels exceeding 1.5 times the ULN); 4) Hepatitis B or C active (HBsAg-positive and/or HBcAb-positive with HBVDNA >= 10^4 copy number or >= 4000 IU/ml; HCV antibody-positive) or human immunodeficiency virus (HIV) antibody-positive); 5) Known propensity to hemorrhage or hemophilia; and 6) Inability to swallow capsules or the presence of disorders that significantly interfere with gastrointestinal function, such as malabsorption syndromes, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction; 7) those deemed unsuitable for enrollment by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Rate of Effectiveness (ORR);Overall survival(OS); | — |
Countries
China
Contacts
Public ContactLiu Hui
Beijing Hospital
Outcome results
None listed