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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

:The aim of this study was to analyze the safety and efficacy of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in the Treatment of Newly Diagnosed Splenic B-cell Lymphoma with Prominent Nucleoli (SBLPN). The main questions it aims to explore the Preliminary Efficacy of the Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) Regimen in the Treatment of Newly Diagnosed SBLPN Patients. To explore the safety of zanubrutinib, obinutuzumab combined with lenalidomide (ZGR) in the treatment of newly diagnosed SBLPN patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Aged 18 to 80 years, male or female

• Histologically or cytologically confirmed SBLPN requiring active treatment;

• No prior systemic therapy for SBLPN received;

• ECOG performance status of 0-2;

• Anticipated life expectancy ≥6 months;

• Laboratory parameters (hematologic and biochemical) meeting the following criteria:

• a. Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L, platelet count ≥50 × 10⁹/L;

• b. Total bilirubin (TBIL) ≤2.0 × upper limit of normal (ULN);

• c. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN;

• d. Creatinine clearance ≥50 mL/min (calculated via Cockcroft-Gault formula or direct measurement).

• Men and women of childbearing potential must agree to use medically approved contraception throughout the study and for 4 weeks after treatment discontinuation;

• Participants must voluntarily enroll in the study and provide written informed consent.

Locations
Other Locations
China
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Contact Information
Primary
Shuhua Yi, Dr
yishuhua@ihcams.ac.cn
+86-022-23909106
Backup
Lugui Qiu, Dr
qiulg@ihcams.ac.cn
86-22-23608108
Time Frame
Start Date: 2025-09-04
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 47
Treatments
Experimental: Induction therapy and maintenance therapy of BGR
1. Induction Therapy Induction Therapy consists of zanubrutinib plus lenalidomide: each cycle lasts 28 days, up to 6 cycles, followed by maintenance therapy.~2. Maintenance Therapy Maintenance therapy consists of zanubrutinib plus lenalidomide: Lenalidomide is continued for 1 year. Zanubrutinib is continued for 2 years.
Related Therapeutic Areas
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov

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