NCT07165769 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
| NCT ID | NCT07165769 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Splenic B-cell Lymphoma/Leukaemia With Prominent Nucleoli，SBLPN |
| Study Type | INTERVENTIONAL |
| Enrollment | 47 participants |
| Start Date | 2025-09-04 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 47 participants in total. It began in 2025-09-04 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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 Criteria
Inclusion Criteria: * 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 Criteria: * 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).
Contact & Investigator
Shuhua Yi, Dr
PRINCIPAL INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Frequently Asked Questions
Who can join the NCT07165769 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Splenic B-cell Lymphoma/Leukaemia With Prominent Nucleoli，SBLPN. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07165769 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07165769 currently recruiting?
Yes, NCT07165769 is actively recruiting participants. Contact the research team at yishuhua@ihcams.ac.cn for enrollment information.
Where is the NCT07165769 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07165769 clinical trial?
NCT07165769 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Shuhua Yi, Dr at Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 47 participants.