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RECRUITING

NCT07165769

PHASE2

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

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09-04

Completion Date

2029-12-31

Last Updated

2025-12-18

Healthy Volunteers

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.

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).

Locations (1)

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

Tianjin, Tianjin Municipality, China