Diffuse large B-cell lymphoma (DLBCL)
Conditions
Interventions
Treatment group:Orelabrutinib in combination with standard chemotherapy (R-CHOP/R-MTX)
Sponsors
The First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with diffuse large B-cell lymphoma (DLBCL) according to the 2021 WHO classification criteria, naïve to treatment before enrollment, and with a CNS-IPI score >=4; 2. Aged 18 to 70 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2; 4. Subjects must have adequate organ function; 5. Female subjects of childbearing potential must use highly effective contraceptive methods starting before the first administration of study drugs and throughout the study, continuing for 3 months after the last dose of orelabrutinib or CHOP regimen, or 12 months after the last dose of rituximab, whichever is longer. Male subjects are eligible if they are vasectomized or agree to use a combination of barrier contraception and the above-mentioned methods during the study and for 3 months after the last dose of orelabrutinib or CHOP regimen, or 12 months after the last dose of rituximab; 6. Life expectancy of at least 6 months; 7. Willing to sign the informed consent form and able to understand and comply with all study requirements.
Exclusion criteria
Exclusion criteria: 1. Prior receipt of systemic treatment for DLBCL; 2. Central nervous system (CNS) involvement by lymphoma; 3. Current presence of clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as defined by the New York Heart Association (NYHA) functional classification, or a history of myocardial infarction within 6 months prior to screening; 4. Known Human Immunodeficiency Virus (HIV) infection; 5. Pregnant or lactating women; 6. Individuals unable to understand or comply with the study protocol, or unable to sign the informed consent form; 7. Patients who are allergic to the study drug and related components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year CNS relapse rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate; Progression free survival;Event-free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactZhen Cai
The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed