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NCT Number: NCT06449885

A Cohort Study in Newly Diagnosed MZL

Describe the clinical features, diagnosis and treatment status, disease course and primary outcomes of different subtypes of marginal zone B-cell lymphoma (MZL), observe the therapeutic efficacy and safety of different treatment modalities.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Marginal zone lymphoma (MZL) originates from the marginal zone of lymphatic follicles and can occur in the spleen, lymph nodes and mucosal lymphoid tissues, and the incidence increases with age. The clinicopathological features of each subtype of MZL are heterogeneous, and their clinical manifestations, biology, etiology, and treatment are all quite heterogeneous, and there is still significant uncertainty about the optimal treatment pathway. This prospective, multicenter, cohort study aims to describe the clinical features, diagnosis and treatment status, disease course and primary outcomes of different subtypes of MZL, and to observe the therapeutic efficacy and safety of different treatment modalities.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age≥ 18 years old; Male or female.
  • Newly diagnosed marginal zone lymphoma by histopathology within the past 6 months (180 days) and no anti-tumor therapy (including chemotherapy, radiotherapy, and biological therapy or immunotherapy for the treatment of tumors).
  • Willing to provide biological samples required for the study, including blood samples and tumor tissue.
  • Voluntarily join this study and sign the informed consent form.
  • Willing to accept long-term follow-up.

Exclusion criteria

  • Patients with HIV infection.
  • Those who cannot come to the hospital regularly for follow-up.
  • Those with comorbidities and speech impairment.

Treatment and study plan

patients receive optimal treatment or follow-up according to the characteristics of the disease

Other

Patients with MZL who are eligible for enrollment will be evaluated by the investigator and the enrolled patients will receive long-term follow-up after collecting medical history information, biological samples, and oncology data according to the study protocol. This study does not specify a detailed treatment modality, and patients receive optimal treatment or follow-up according to the characteristics of the disease.

Primary outcomes

  1. Progression-free survival

    Time frame: assessed up to 10 years

    record the period from date of patients sign informed consent until the date of documented progression or date of death from any cause, whichever came first

Secondary outcomes

  1. Time to treatment

    Time frame: assessed up to 10 years

    calculate the time interval between the start of diagnosis and the first dose of anti-tumor therapy.

  2. Time to next treatment

    Time frame: assessed up to 10 years

    the time interval from initiation of treatment to initiation of next-line anti-neoplastic therapy or death due to any cause.

  3. ORR

    Time frame: up to 6 months

    the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment

  4. Overall survival

    Time frame: assessed up to 10 years

    time between the date of patients sign informed consent and the date of death or the date of last follow-up time

  5. Adverse events

    Time frame: Throughout the treatment period, up to 10 years

    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

  6. Histologic transformation rate

    Time frame: Throughout the study, up to 10 years

    Proportion of patients with histologic transformation in all patients

  7. Occurrence rate of a second tumor

    Time frame: Throughout the study, up to 10 years

    Proportion of patients with a second tumor in all patients

Other outcomes

  1. serum biomarkers

    Time frame: Throughout the study, up to 10 years

    detection of serum DNA biomarkers in the treatment of marginal zone lymphoma

  2. tissue biomarkers

    Time frame: Throughout the study, up to 10 years

    detection of tissue DNA biomarkers in the treatment of marginal zone lymphoma

Study contacts

Contact information is provided by the study sponsor or research team.

Rong Tao, M.D

CONTACT

[email protected]

86-21-64175590

Yizhen Liu, M.D., Ph.D.

CONTACT

[email protected]

86-21-64175590

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Prospective, Multi-center, Cohort Study in Newly Diagnosed Marginal Zone B-cell Lymphoma

Important dates

Study start
2024
Primary completion
2029
Study completion
2034
First posted
Jun 10, 2024
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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