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Zanubrutinib and Rituximab Followed by R-DHAOx Then Maintenance with Zanubrutinib for Newly-Diagnosed MCL
Sponsor: Sun Yat-sen University
Summary
This phase 2 trial studies the efficacy and safety of zanubrutinib plus rituximab followed by R-DHAOx (rituximab, dexamethasone, cytarabine and oxaliplatin) regimen then maintenance with zanubrutinib for newly-diagnosed Mantle Cell Lymphoma (MCL).
Official title: Zanubrutinib and Rituximab Followed by R-DHAOx (Rituximab, Dexamethasone, Cytarabine and Oxaliplatin) Regimen Then Maintenance with Zanubrutinib for Newly-Diagnosed Mantle Cell Lymphoma (MCL): a Single Arm, Open Label, Multi-center Phase II Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2020-12-01
Completion Date
2026-12
Last Updated
2024-10-18
Healthy Volunteers
No
Interventions
Zanubrutinib and Rituximab
Zanubrutinb 160mg PO BID d1-28; Rituximab 375mg/m2 iv.drip d1.
R-DHAOx
Rituximab 375mg/m2 iv.drip d1; Dexamethasone 20mg iv.drip d1-4; Cytarabine 2000mg/m2 (1000mg/m2 for patients aged over 65) iv.drip d2,3 Oxaliplatin 130mg/m2 iv.drip d1.
Zanubrutinib Maintenance
Zanubrutinb 160mg PO BID.
Locations (3)
Guangdong General Hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China