Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors
NCT05887726 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2023-07-27
Summary
This study is a prospective, open-label, single-arm phase II clinical study to evaluate the safety and efficacy of zanubrutinib plus R-CHOP (ZR-CHOP) as the first-line therapy for newly diagnosed diffuse large B-cell lymphoma patients with high-risk factors.
Conditions
Interventions
- DRUG
-
Zanubrutinib 160mg bid p.o d0-d20(21-day cycles)
- DRUG
-
Rituximab 375 mg/m2 i.v d0(21-day cycles)
- DRUG
-
Cyclophosphamide 750 mg/m2 i.v d1(21-day cycles)
- DRUG
-
Epirubicin
Epirubicin 75 mg/m2 i.v d1 or liposome adriamycin 35mg/m2 i.v d1(21-day cycles)
- DRUG
-
Vincristine
Vincristine 1.4 mg/m2 i.v d1 (2 mg max) (21-day cycles)
- DRUG
-
Prednisone 100 mg p.o d1-d5 (21-day cycles)
Sponsors & Collaborators
-
Liaoning Cancer Hospital & Institute
lead OTHER
Principal Investigators
-
Xiaojing Xing, Ph.D · Liaoning Cancer Hospital & Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-01
- Primary Completion
- 2024-08-01
- Completion
- 2025-08-01
Countries
- China
Study Locations
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