Zanubrutinib Combined With R-CHOP in Newly-diagnosed Intravascular Large B-cell Lymphoma
NCT04899570 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2021-05-24
Summary
This is a prospective single-arm phase II study, and the purpose of this study is to evaluate the efficiency of zanubrutinib combined with R-CHOP regimen in newly diagnosed primary intraocular lymphoma. Progression-free survival (PFS) of the cohort is the primary endpoint.
Conditions
- Intravascular Large B-Cell Lymphoma
Interventions
- DRUG
-
160mg Bid, oral, d1-21 in a 21-day cycle for 8 cycles.
- DRUG
-
Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol
- DRUG
-
Cyclophosphamide 750mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol
- DRUG
-
Epirubicin
Epirubicin 70mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol
- DRUG
-
Vindesine
Vindesine 4mg intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be rescribed as protocol
- DRUG
-
Prednisone 60mg/m2 orally d1-5, every 21 days for 1 cycle. 8 cycles will be rescribed as protocol
Sponsors & Collaborators
-
Peking Union Medical College Hospital
lead OTHER
Principal Investigators
-
Daobin Zhou · Department of Hematology, Peking University First Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-01
- Primary Completion
- 2023-04-01
- Completion
- 2025-04-01
Countries
- China
Study Locations
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