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

NCT07165769 | Recruiting Phase 2

• 1 other identifier: IIT2025004
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Splenic B-cell Lymphoma/Leukaemia With Prominent Nucleoli，SBLPN

Outcome Measures

Primary Outcomes (1)

• Objective response rate，ORR

  defined as the proportion of patients with complete or partial response as assessed by response to induction therapy.

  up to the end of 9 cycles of treatment(each cycle is 28 days)]

Secondary Outcomes (6)

• complete response rate，CRR

  Up to the end of 9 cycles of treatment(each cycle is 28 days)

• progression-free survival，PFS

  up to 5 years

• duration of response，DOR

  up to 5 years

• Overall survival，OS

  Up to 5 years

• Minimal Residual Disease，MRD

  Up to the end of 2 years (each cycle is 28 days)

Study Arms (1)

Induction therapy and maintenance therapy of BGR

EXPERIMENTAL

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.

Drug: Induction Therapy; Drug: Maintenance Therapy

Interventions

Maintenance Therapy DRUG

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.

Induction therapy and maintenance therapy of BGR

Induction Therapy DRUG

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.

Induction therapy and maintenance therapy of BGR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

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

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Interventions

Neoadjuvant Therapy; Maintenance

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Health Care Facilities Workforce and Services

Study Officials

• Shuhua Yi, Dr

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuhua Yi, Dr

CONTACT

+86-022-23909106; yishuhua@ihcams.ac.cn

Lugui Qiu, Dr

CONTACT

86-22-23608108; qiulg@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: September 4, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)