Zanubrutinib, Rituximab, and Lenalidomide in the First-Line Treatment of Marginal Zone Lymphoma

NCT07299331 | Not Yet Recruiting DMC

• 1 other identifier: 2025-KY-1174-002
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if Zanubrutinib, Rituximab, and Lenalidomide works to treat marginal zone lymphoma as the first-line therapy. It will also learn about the safety of the treatment. The main questions it aims to answer are Does the combined therapy prolong patient survival? What medical problems do participants have when using this therapeutic approach? Researchers will observe the treatment to see if it works well than conventional therapies. Participants will Administer drugs as required by the protocol Visit the clinic regularly for checkups and tests Keep a diary of their symptoms, examination and laboratory test indicators

Conditions

Marginal Zone Lymphoma(MZL)

Outcome Measures

Primary Outcomes (1)

• CRR

  Complete remission rate

  2 years

Secondary Outcomes (6)

• ORR

  2 years

• 2 year-progress free survival rate

  2 years

• TTR

  From randomization up to 24 months post-randomization

• DoR

  From the date of first confirmed CR/PR up to 24 months post-confirmed response

• OS

  From randomization up to 24 months post-randomization

Study Arms (1)

Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone Lymphoma

EXPERIMENTAL

Drug: Zanubrutinib, Rituximab, and Lenalidomide as first-line treatment for Marginal Zone Lymphoma; Drug: Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone Lymphoma

Interventions

Zanubrutinib, Rituximab, and Lenalidomide as first-line treatment for Marginal Zone Lymphoma DRUG

This study enrolls patients with marginal zone lymphoma who require the primary treatment. Participants receive a combined therapy consisting of zanubrutinib, rituximab, and lenalidomide.

Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone Lymphoma

Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone Lymphoma DRUG

This study enrolls patients with marginal zone lymphoma who require the primary treatment. Participants receive a combined therapy consisting of zanubrutinib, rituximab, and lenalidomide.

Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone Lymphoma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• Histologically confirmed MZL in untreated stage III or IV and needed for therapy as determined by the treating physician
• ECOG performance status 0-2
• Expected survival ≥ 6 months
• Adequate hematologic and organ function: absolute neutrophil count ≥1,000/mm3 (independent of growth factor support), platelet counts ≥75,000/mm3, serum aspartate transaminase or alanine transaminase less than 2.5 times the upper limit of normal (ULN), serum creatinine ≤1.5×ULN, and bilirubin ≤1.5×ULN unless bilirubin is due to Gilbert's syndrome, documented liver involvement with lymphoma, or of nonhepatic origin, in which case bilirubin should not exceed 3 g/dL, left ventricular ejection fraction (LVEF) of the heart≥ 50%
• Women of childbearing potential and men who were sexually active were required to be practicing a highly effective method of birth control during and after the study
• No history of other malignant tumors
• At least one measurable lesion with a longest diameter of ≥ 1.5 cm or measurable lesions of extranodal lesions ≥ 1.0 cm.
• Able to understand the study and provide signed Informed Consent Form

You may not qualify if:

• Pregnant or lactating women
• Active central nervous system lymphoma
• Previous anti-tumor treatment
• A severe immediate-type hypersensitivity reaction history for any of the drugs used in this study
• History of stroke or intracranial hemorrhage within 6 months before study entry
• Received a live attenuated vaccine within 4 weeks prior to enrollment History of human immunodeficiency virus, or active hepatitis C virus, or active hepatitis B virus infection, or any uncontrolled active systemic infection
• Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
• Other serious medical conditions that might have an impact on this study

Sponsors & Collaborators

• Zhengzhou University: lead

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

zanubrutinib; Rituximab; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 23, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): April 30, 2031
• Study Completion (Estimated): April 30, 2031
• Last Updated: December 23, 2025

Record last verified: 2025-07