Registry Study of Chinese Patients With Marginal Zone Lymphoma (MOTIVE)
NCT Number: NCT06534463
Acronym: MOTIVE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Marginal Zone Lymphoma
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.
Sponsor: Ruijin Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2029-09-01

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.

Primary Outcome Measures: Progression-free survival, 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., Baseline up to data cut-off (up to approximately 60 months)
Secondary Outcome Measures: Overall Response Rate, Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria., End of treatment visit (approximately 6 months)|Complete Response Rate, Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria., End of treatment visit (approximately 6 months)|Time to Next Treatment, From the start of treatment to the initiation of next-line treatment, From the start of treatment to the initiation of next-line treatment (up to approximately 60 months)|Duration of Response, Time from first occurrence of documented complete response or partial response to disease progression/relapse, or death from any cause for participants, whichever occurs first., Baseline up to data cut-off (up to approximately 60 months)|Duration of Complete Response, Time from the first occurrence of a documented complete response to the date of progression, relapse, or death from any cause, whichever occurs first., Baseline up to data cut-off (up to approximately 60 months)|Overall survival, Overall survival was defined as the time from the date of diagnosis to the date of death from any cause., Baseline up to data cut-off (up to approximately 60 months)|Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events., Baseline up to data cut-off (up to approximately 60 months)
Other Outcome Measures: Health-Related Quality of Life assessed with EORTC QLQ-C30 questionaire, Patient-reported outcomes using The European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30) ., Baseline up to data cut-off (up to approximately 60 months)|Health-Related Quality of Life assessed with EORTC QLQ-NHL-LG20 questionaire, Patient-reported outcomes using The European Organization for Research and Treatment of Cancer Quality of Life questionnaire including 20 items for patients with low-grade non-Hodgkin lymphoma (EORTC QLQ-NHL-LG20)., Baseline up to data cut-off (up to approximately 60 months)