Study of Zanubrutinib, Rituximab and Combination Chemotherapy in Newly-diagnosed Aggressive B-cell Non-Hodgkin Lymphoma

This is an interventional treatment trial for High Grade B-Cell Lymphoma, Not Otherwise Specified Read More

Inclusion Criteria:

1. Age ≥18 years, gender not limited
2. Newly and histologically diagnosed aggressive B-NHL
3. Patients who have not received systematic chemotherapy or immunotherapy;
4. Patients with at least ≥1 tumor foci with a measurable maximum axis exceeding 1.5 cm;
5. Eastern cancer collaboration group(ECOG) physical status score: 0-2
6. a)Blood routine: (independent of growth factor support or transfusion within 7 days of study entry) neutrophils absolute value ≥1.5×109/L, platelets ≥75×109/L, b) Coagulation function: INR ≤2.5 times ULN, c) Blood biochemistry: total bilirubin ≤2 times ULN, AST or ALT≤2.5 times ULN d) Ccr ≥ 30 mL/min;
7. expected survival time ≥3 months;
8. Willing to take contraceptive measures during the trial period and within 1 week after the trial ends;
9. Voluntarily sign written informed consent before screening.

Exclusion Criteria:

1. Current or previous malignancy, unless radical therapy has been performed and there is no evidence of recurrence or metastasis in the past 5 years;
2. Patients scheduled for major surgery(except for examination for diagnostic purposes) within 4 weeks or participating in drug/device clinical trials;
3. Prior or concurrent indolent B-cell lymphoma transformation;
4. Uncontrolled or significant cardiovascular disease;
5. Had active bleeding within 2 months prior to screening, or was taking anticoagulant drugs, or was considered by the investigator to have a clear tendency to bleeding;
6. Stroke or intracranial hemorrhage within 6 months;
7. Subjects with clinically significant gastrointestinal abnormalities that may affect drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.)
8. Active or uncontrolled HBV (HBsAg positive and HBV DNA titer positive), HCV Ab positive or HIV positive;
9. Uncontrolled, active systemic fungal, bacterial, viral, or other infections (defined as showing persistent signs/symptoms related to infection, despite the use of appropriate antibiotics or other treatments without improvement)
10. Allergies or hypersensitivity reactions to zanubrutinib, rituximab or any other component of the applicable study drug;