47
Participants
Start Date
September 4, 2025
Primary Completion Date
December 31, 2028
Study Completion Date
December 31, 2029
Induction Therapy
"All enrolled patients will receive the ZGR regimen (zanubrutinib, obinutuzumab, and lenalidomide) for induction therapy. Each cycle lasts 28 days, up to 6 cycles, followed by maintenance therapy. Patients experiencing disease progression during induction will discontinue the trial drugs but remain under survival follow-up.~1. Zanubrutinib: 160 mg twice daily, administered orally continuously.~2. Obinutuzumab: 1000 mg via intravenous infusion, administered on Days 1, 8, and 15 of Cycle 1 and subsequently on Day 1 of Cycles 2-6.~3. Lenalidomide: 25 mg once daily, taken orally on Days 1-21 of each 28-day cycle until disease progression. Doses should be taken at approximately the same time daily."
Maintenance Therapy
"Maintenance therapy consists of zanubrutinib plus lenalidomide:~Lenalidomide is continued for 1 year. Zanubrutinib is continued for 2 years. Treatment continues until disease progression, intolerability, or completion of 2 years. For patients who do not achieve complete remission (CR), therapy may continue until progression or intolerability.~1. Zanubrutinib: 160 mg twice daily, administered orally continuously.~2. Lenalidomide: 10 mg once daily, taken orally on Days 1-21, followed by a 7-day rest period, constituting a 28-day cycle."
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences, Tianjin
Institute of Hematology & Blood Diseases Hospital, China
OTHER