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

Ruijin Hospital1 site in 1 country500 target enrollmentAugust 2, 2024

ConditionsMarginal Zone Lymphoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Marginal Zone Lymphoma
Sponsor: Ruijin Hospital
Enrollment: 500
Locations: 1
Primary Endpoint: Progression-free survival
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2, 2024

End Date

September 1, 2029

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Ruijin Hospital

Responsible Party

Principal Investigator

Zhao Weili

Deputy director of hospital

Ruijin Hospital

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.

Outcomes

Primary Outcomes

Progression-free survival

Time Frame: Baseline up to data cut-off (up to approximately 60 months)

Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

Secondary Outcomes

Overall Response Rate(End of treatment visit (approximately 6 months))
Complete Response Rate(End of treatment visit (approximately 6 months))
Time to Next Treatment(From the start of treatment to the initiation of next-line treatment (up to approximately 60 months))
Duration of Response(Baseline up to data cut-off (up to approximately 60 months))
Duration of Complete Response(Baseline up to data cut-off (up to approximately 60 months))
Overall survival(Baseline up to data cut-off (up to approximately 60 months))
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to data cut-off (up to approximately 60 months))