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Marginal Zone Lymphoma(MZL)NCT07299331

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

A study testing Zanubrutinib, Rituximab, and Lenalidomide as first-line treatment for Marginal Zone Lymphoma and Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone Lymphoma in people with Marginal Zone Lymphoma(MZL), run by Zhengzhou University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Marginal Zone Lymphoma(MZL)
What is being tested?
Zanubrutinib, Rituximab, and Lenalidomide as first-line treatment for Marginal Zone Lymphoma and Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone Lymphoma
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
1 Jan 2026to 30 Apr 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

About this study

Official title: A Multicenter, Single-Arm, Prospective Clinical Study of Zanubrutinib, Rituximab, and Lenalidomide in the First-Line Treatment of Marginal Zone Lymphoma

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

Being tested
Zanubrutinib, Rituximab, and Lenalidomide as first-line treatment for Marginal Zone Lymphoma, Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone Lymphoma
Medical subject headings
Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zanubrutinib, Rituximab, and Lenalidomide as first-line treatment for Marginal Zone LymphomaDrug

    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 LymphomaDrug

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

Study groups in NCT07299331
Study groupRoleWhat they receive
Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone LymphomaExperimentalNot described
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CRR

    Complete remission rate

    Measured: 2 years

Secondary outcomes (6)

  1. ORR

    Objective response rate

    Measured: 2 years

  2. 2 year-progress free survival rate

    the time from the start of treatment to the time when the patient has progressed on the disease or dies due to any cause in 2 years.

    Measured: 2 years

  3. TTR

    Time from randomization to the first documentation of Complete Response (CR) or Partial Response (PR) , verified by computed tomography (CT) and positron emission tomography (PET)-CT at least 6 weeks apart

    Measured: From randomization up to 24 months post-randomization

  4. DoR

    The interval from the date of first confirmed OR to the first evidence of progressive disease or death from any cause

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

  5. OS

    The time from the date of randomization to the date of death from any cause

    Measured: From randomization up to 24 months post-randomization

  6. Incidence rate of adverse events

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2025
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion30 Apr 2031 (estimated)
  4. Study completion30 Apr 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07299331
Sponsor's protocol ID
2025-KY-1174-002
Status last verified
Jul 2025
First submitted
1 Dec 2025
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Zanubrutinib, Rituximab, and Lenalidomide as first-line treatment for Marginal Zone Lymphoma and Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone Lymphoma in people with Marginal Zone Lymphoma(MZL), run by Zhengzhou University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CRR (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07299331.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

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