Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in the Treatment of Newly Diagnosed Splenic B-cell Lymphoma With Prominent Nucleoli (SBLPN): A Prospective, Open-label, Single-arm Clinical Trial

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

September 4, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2029

Conditions
Splenic B-cell Lymphoma/Leukaemia With Prominent Nucleoli,SBLPN
Interventions
DRUG

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."

DRUG

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."

Trial Locations (1)

300020

Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences, Tianjin

All Listed Sponsors
lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER