Actively Recruiting
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
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-12-18
47
Participants Needed
1
Research Sites
225 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
: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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 of at least 6 months
- Laboratory values meeting all of the following: ANC 1.0 10/L, platelet count 50 10/L; total bilirubin 2.0 upper limit of normal; ALT and AST 2.5 upper limit of normal; creatinine clearance 50 mL/min
- Men and women of childbearing potential must agree to use medically approved contraception during the study and for 4 weeks after treatment
- Participants must voluntarily enroll and provide written informed consent
You will not qualify if you...
- History of central nervous system disorders including CNS lymphoma within 1 year prior to enrollment
- Other primary malignancies within past 3 years except certain treated localized cancers
- Participation in other investigational drug or interventional trials within 4 weeks prior to enrollment
- Major surgery within 14 days before enrollment or planned during study
- Prior use of investigational agents targeting SBLPN
- Active immunodeficiency, autoimmune diseases, or recent immunosuppressive therapy
- Severe liver dysfunction, cachexia, multiorgan failure, or severe kidney impairment
- Significant cardiovascular conditions including NYHA class III/IV heart failure, recent myocardial infarction, uncontrolled arrhythmias, poorly controlled hypertension, or unstable angina
- Bleeding disorders or thrombotic events within 3 months
- Hypersensitivity to study drug ingredients
- Pregnancy, lactation, or unwillingness to use contraception if of childbearing potential
- Any other conditions that may interfere with study participation or safety as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
S
Shuhua Yi, Dr
CONTACT
L
Lugui Qiu, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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