Registry Study of Chinese Patients with Marginal Zone Lymphoma (MOTIVE)
- 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.
- Registration Number
- NCT06534463
- Lead Sponsor
- Ruijin Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Be diagnosed as MZL
- Meet the treatment indications for MZL
- Any reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational Cohort All treatment regimen selections and usage will be determined by the physician based on clinical practice and/or the respective drug labels in China. Including newly diagnosed marginal zone lymphoma (MZL) and relapse/refractory MZL participants who meet the treatment indications for MZL and are about to undergo MZL treatment.
- Primary Outcome Measures
Name Time Method Progression-free survival 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 Outcome Measures
Name Time Method Overall Response Rate End of treatment visit (approximately 6 months) Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Complete Response Rate End of treatment visit (approximately 6 months) Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time to Next Treatment From the start of treatment to the initiation of next-line treatment (up to approximately 60 months) From the start of treatment to the initiation of next-line treatment
Duration of Response Baseline up to data cut-off (up to approximately 60 months) 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.
Duration of Complete Response Baseline up to data cut-off (up to approximately 60 months) Time from the first occurrence of a documented complete response to the date of progression, relapse, or death from any cause, whichever occurs first.
Overall survival Baseline up to data cut-off (up to approximately 60 months) Overall survival was defined as the time from the date of diagnosis to the date of death from any cause.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline up to data cut-off (up to approximately 60 months) 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.
Trial Locations
- Locations (1)
Shanghai Ruijin Hospital
🇨🇳Shanghai, Shanghai, China