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Recruiting NCT06534463

Registry Study of Chinese Patients with Marginal Zone Lymphoma (MOTIVE)

— Observational 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: All treatment regimen selections and usage will be determined by the physician based on clinical practice and/or the respective drug labels in China..
Who it may be relevant to
Registry conditions: Marginal Zone Lymphoma. Basic parameters: from 14 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
China
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

The Effectiveness and Safety of Different Treatment Modalities in Real-World Clinical Practice Among Chinese Patients with Marginal Zone Lymphoma: a Prospective, Observational, Multi-center Study

Overview

This study aims to evaluate real-world treatment modalities and their corresponding effectiveness and safety in Chinese patients with marginal zone lymphoma, while also exploratively analyzing patient characteristics and health-related quality of life.

Interventions

  • Other All treatment regimen selections and usage will be determined by the physician based on clinical practice and/or the respective drug labels in China.
    The dosage and duration of any drug in this study will be determined by the physician based on local clinical practice and local drug labels. The drugs in this study include, but are not limited to, Obinutuzumab, Rituximab, Bruton tyrosine kinase inhibitors, and Lenalidomide. In this non-interventional study, all treatment drug usage will be determined by the physician based on clinical practice and/or the respective drug labels in China.

Primary outcome measures

  • Progression-free survival [Time frame: Baseline up to data cut-off (up to approximately 60 months)]
Secondary outcome measures (7)
  • Overall Response Rate [Time frame: End of treatment visit (approximately 6 months)]
  • Complete Response Rate [Time frame: End of treatment visit (approximately 6 months)]
  • Time to Next Treatment [Time frame: From the start of treatment to the initiation of next-line treatment (up to approximately 60 months)]
  • Duration of Response [Time frame: Baseline up to data cut-off (up to approximately 60 months)]
  • Duration of Complete Response [Time frame: Baseline up to data cut-off (up to approximately 60 months)]
  • Overall survival [Time frame: Baseline up to data cut-off (up to approximately 60 months)]
  • Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Baseline up to data cut-off (up to approximately 60 months)]

Eligibility criteria

Inclusion criteria

  • Be diagnosed as MZL
  • Meet the treatment indications for MZL

Exclusion criteria

  • Any reason that, in the investigator's opinion, makes the participant unsuitable to participate in 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

Observational model
Cohort

Study locations

China · 1 center
  • Shanghai Ruijin Hospital — Shanghai

Identifiers

NCT: NCT06534463 · MOTIVE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗