ZGR: zanubrutinib plus obinutuzumab and lenalidomide for newly diagnosed splenic B‑cell lymphoma with prominent nucleoli

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

There is no established optimal first‑line therapy for splenic B‑cell lymphoma with prominent nucleoli (SBLPN), and existing regimens can cause significant toxicity or resistance. This single‑arm phase 2 trial gives untreated patients six cycles of induction therapy with zanubrutinib, obinutuzumab, and lenalidomide (ZGR), followed by maintenance zanubrutinib plus lenalidomide. The study measures preliminary efficacy outcomes and monitors safety and tolerability throughout treatment. The design aims to determine whether the targeted BTK inhibition plus enhanced anti‑CD20 antibody activity and immunomodulation can improve responses and survival with acceptable side effects in this rare disease.

Why it matters

Who can join: the full rules

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).

Where it's running

• Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Shuhua Yi, Dr — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Shuhua Yi, Dr
• Email: yishuhua@ihcams.ac.cn
• Phone: +86-022-23909106

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Combining zanubrutinib and obinutuzumab for untreated chronic lymphocytic leukemia or small lymphocytic lymphoma

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• Zanubrutinib plus Lenalidomide for frail elderly with newly diagnosed PCNSL

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.