Status:
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
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Splenic B-cell Lymphoma/Leukaemia With Prominent Nucleoli，SBLPN
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
There is no consensus on optimal first-line therapy for splenic B-cell lymphoproliferative neoplasms (SBLPN). Existing regimens like cladribine/bendamustine plus rituximab face toxicity and resistance...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- History of central nervous system (CNS) disorders (including CNS lymphoma) diagnosed within 1 year prior to enrollment.
- Other primary malignancies within the past 3 years (excluding non-melanoma skin cancer, curatively treated localized prostate cancer, cervical carcinoma in situ, or squamous intraepithelial lesions on PAP smear).
- Exposure to any investigational drugs, antimicrobial agents, or participation in other interventional clinical trials within 4 weeks prior to enrollment.
- Major surgery (excluding lymph node biopsy) within 14 days before enrollment or anticipated requirement for major surgery during the study.
- Prior use of investigational agents targeting SBLPN.
- Active immunodeficiency, autoimmune diseases, prolonged systemic corticosteroid therapy (\>10 mg/day prednisone equivalent) within 7 days prior to enrollment, or any immunosuppressive therapy.
- Severe hepatic dysfunction (e.g., severe jaundice, hepatic encephalopathy, refractory ascites, hepatorenal syndrome), cachexia, multiorgan failure, or severe renal impairment.
- Clinically significant cardiovascular comorbidities:
- New York Heart Association (NYHA) class III/IV heart failure; Myocardial infarction within 6 months prior to enrollment; Uncontrolled arrhythmias (including QTc interval ≥480 ms); Poorly controlled hypertension (systolic ≥150 mmHg/diastolic ≥100 mmHg despite antihypertensives); Unstable angina.
- Bleeding diathesis or coagulation disorders; thrombotic events within 3 months prior to enrollment.
- Hypersensitivity to active ingredients or excipients of the investigational drugs.
- Pregnancy, lactation, or women of childbearing potential unwilling/unable to use contraception.
- Other conditions deemed unsuitable for participation by the investigator (e.g., compromised protocol compliance or safety risks).
Key Trial Info
Start Date :
September 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT07165769
Start Date
September 4 2025
End Date
December 31 2029
Last Update
December 18 2025
Active Locations (1)
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1
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020