Zanubrutinib-based Induction and Maintenance Therapy in Young and Fit Patients With Untreated Mantle Cell Lymphoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

January 31, 2021

Primary Completion Date

January 31, 2023

Study Completion Date

February 28, 2026

Conditions
Mantle Cell Lymphoma
Interventions
DRUG

R-CHOP/R-DHAOx; Zanubrutib(induction); ASCT conditioning ; Zanubrutinib(Maintenance)

"Alternating 3× R-CHOP/ 3× R-DHAOx, every 21 days plus oral Zanubrutinib in cycle 1, 3, 5 in combination with R-CHOP:~R-CHOP (cycle 1,3,5):~Rituximab 375 mg/m2 D1, I.V. Cyclophosphamide 750 mg/m2 D1, I.V. Doxorubicine 50 mg/m2 D1, I.V. Vincristine 1.4mg/m2(max 2mg)D1, I.V. Prednisone 100mg D1-5, oral Zanubrutinib 160mg BID D1-21, oral~R-DHAOx (cycle 2,4,6):~Dexamethasone 40mg D1-4 oral/I.V. Rituximab 375mg/m2 D1, I.V. Ara-C 2×2g/m2 q12h D2, I.V. Cisplatin 100mg/m2 D1, I.V.~Maintenance:~* Zanubrutinib, 160mg PO BID, continuously for 2 year or until progressive disease。~* Zanubrutinib maintenance will start after regeneration of peripheral blood count after the end of the last cycle of induction therapy or ASCT"

Trial Locations (1)

510060

RECRUITING

Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER