A Single-arm, Single-center, Open-label Phase II Study of Zanubrutinib Combined With R-CHOP/R-DHAP in Newly Diagnosed Mantle CellLymphoma Patients

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

March 15, 2024

Primary Completion Date

January 1, 2026

Study Completion Date

December 1, 2027

Conditions
Mantle Cell Lymphoma
Interventions
DRUG

Zanubrutinib and RCHOP/RDHAP

"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-DHAP(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, rituximab 375mg/m2 repeated every 8 weeks, treatment will continue for up to 2 years or until progressive disease。"

Trial Locations (1)

030013

Hematology Department of ShanXi Cancer Hospital, Taiyuan

All Listed Sponsors
lead

Shanxi Province Cancer Hospital

OTHER