Marginal Zone Lymphoma
Conditions
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.
Interventions
OTHERAll 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.
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life assessed with EORTC QLQ-C30 questionaire | Baseline up to data cut-off (up to approximately 60 months) | Patient-reported outcomes using The European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30) . |
| Health-Related Quality of Life assessed with EORTC QLQ-NHL-LG20 questionaire | Baseline up to data cut-off (up to approximately 60 months) | 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). |
Countries
China
Contacts
Primary ContactWeili Zhao
Outcome results
None listed