Last updated: December 7, 2021
Sponsor: Shandong Provincial Hospital
Overall Status: Active - Recruiting
Phase
3
Condition
Lymphoma
Lymphoma, B-cell
Lymphoproliferative Disorders
Treatment
N/AClinical Study ID
NCT05164770
B-NHL002
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥18 years, gender not limited
- Newly and histologically diagnosed aggressive B-NHL
- Patients who have not received systematic chemotherapy or immunotherapy;
- Patients with at least ≥1 tumor foci with a measurable maximum axis exceeding 1.5 cm;
- Eastern cancer collaboration group(ECOG) physical status score: 0-2
- a)Blood routine: (independent of growth factor support or transfusion within 7 days ofstudy 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 ≤2times ULN, AST or ALT≤2.5 times ULN d) Ccr ≥ 30 mL/min;
- expected survival time ≥3 months;
- Willing to take contraceptive measures during the trial period and within 1 week afterthe trial ends;
- Voluntarily sign written informed consent before screening.
Exclusion
Exclusion Criteria:
- Current or previous malignancy, unless radical therapy has been performed and there isno evidence of recurrence or metastasis in the past 5 years;
- Patients scheduled for major surgery(except for examination for diagnostic purposes)within 4 weeks or participating in drug/device clinical trials;
- Prior or concurrent indolent B-cell lymphoma transformation;
- Uncontrolled or significant cardiovascular disease;
- Had active bleeding within 2 months prior to screening, or was taking anticoagulantdrugs, or was considered by the investigator to have a clear tendency to bleeding;
- Stroke or intracranial hemorrhage within 6 months;
- Subjects with clinically significant gastrointestinal abnormalities that may affectdrug intake, transport or absorption (such as inability to swallow, chronic diarrhea,intestinal obstruction, etc.)
- Active or uncontrolled HBV (HBsAg positive and HBV DNA titer positive), HCV Abpositive or HIV positive;
- Uncontrolled, active systemic fungal, bacterial, viral, or other infections (definedas showing persistent signs/symptoms related to infection, despite the use ofappropriate antibiotics or other treatments without improvement)
- Allergies or hypersensitivity reactions to zanubrutinib, rituximab or any othercomponent of the applicable study drug;
Study Design
Total Participants: 160
Study Start date:
March 01, 2021
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Department of Hematology, Shandong Provincial Hospital
Jinan, Shandong 250021
ChinaActive - Recruiting
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