Zanubrutinib, Rituximab, and Lenalidomide in the First-Line Treatment of Marginal Zone Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zanubrutinib, Rituximab, and Lenalidomide as first-line treatment for Marginal Zone Lymphoma, Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone Lymphoma.
- Who it may be relevant to
- Registry conditions: Marginal Zone Lymphoma(MZL). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Single-Arm, Prospective Clinical Study of Zanubrutinib, Rituximab, and Lenalidomide in the First-Line Treatment of Marginal Zone Lymphoma
Overview
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
Interventions
- Drug Zanubrutinib, Rituximab, and Lenalidomide as first-line treatment for Marginal Zone Lymphoma
This study enrolls patients with marginal zone lymphoma who require the primary treatment. Participants receive a combined therapy consisting of zanubrutinib, rituximab, and lenalidomide. - Drug Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone Lymphoma
This study enrolls patients with marginal zone lymphoma who require the primary treatment. Participants receive a combined therapy consisting of zanubrutinib, rituximab, and lenalidomide.
Primary outcome measures
- CRR [Time frame: 2 years]
Secondary outcome measures (6)
- ORR [Time frame: 2 years]
- 2 year-progress free survival rate [Time frame: 2 years]
- TTR [Time frame: From randomization up to 24 months post-randomization]
- DoR [Time frame: From the date of first confirmed CR/PR up to 24 months post-confirmed response]
- OS [Time frame: From randomization up to 24 months post-randomization]
- Incidence rate of adverse events [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 18-75 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07299331 · 2025-KY-1174-002