Mantle Cell Lymphoma
Conditions
Brief summary
This study with retrospective data collection does not entail sample size calculation. The study will involve patients who received bendamustine + rituximab for relapsed/refractory mantle cell lymphoma and meet the inclusion/exclusion criteria at each participating study site. Considering the incidence of mantle cell lymphoma in Korea and the number of participating sites, the expected sample size is approximately 40.
Detailed description
1. Inclusion criteria : Patients newly diagnosed with mantle cell lymphoma by a pathologist (based on the 2016 revision of the WHO classification) 1) mantle cell lymphoma 2) leukemic non-nodal mantle cell lymphoma 3) in situ mantle cell neoplasia 2. Age ≥ 19 years 3. Patients who received bendamustine + rituximab as initial therapy and patients who received bendamustine + rituximab for the treatment of relapsed/refractory condition are both included. 2\. Exclusion criteria : 1. Patients whose clinical and pathological data are not available 2. Patients who were not treated with a combination of bendamustine and rituximab Data of patients who received bendamustine + rituximab for relapsed/refractory mantle cell lymphoma collected before the date of first submission of an IRB application for new project will be analyzed. The aim is to publish the data analysis and study results before December 2020. The expected overall study period is until December 2020.
Interventions
DRUGBendamustine
To investigate the efficacy and safety of bendamustine plus rituximab in patients with mantle cell lymphoma.
Sponsors
Samsung Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 1\. Patients newly diagnosed with mantle cell lymphoma by a pathologist (based on the 2016 revision of the WHO classification) 1. mantle cell lymphoma 2. leukemic non-nodal mantle cell lymphoma 3. in situ mantle cell neoplasia 2. Age ≥ 19 years 3. Patients who received bendamustine + rituximab as initial therapy and patients who received bendamustine + rituximab for the treatment of relapsed/refractory condition are both included.
Exclusion criteria
* 1\. Patients whose clinical and pathological data are not available 2. Patients who were not treated with a combination of bendamustine and rituximab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate, | 2020.12.30 | Overall response rate, including complete response and partial response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 2020.12.30 | The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse |
| Overall survival | 2020.12.30 | The percentage of people in a study or treatment group still alive for a given period of time after diagnosis |
| Duration of response | 2020.12.30 | Duration of response |
| Treatment-emergent adverse event | 2020.12.30 | Treatment-emergent adverse event |
| Prognostic factor | 2020.12.30 | Prognostic factor |
Countries
South Korea
Contacts
Primary ContactKim wonseog, Professor
Backup ContactKim seokjin
Outcome results
None listed