Trials / Unknown
UnknownNCT04127916
Bendamustine Plus Rituximab for Mantle Cell Lymphoma: a Multicenter Retrospective Analysis(BR-MCL)
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (estimated)
- Sponsor
- Samsung Medical Center · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bendamustine | To investigate the efficacy and safety of bendamustine plus rituximab in patients with mantle cell lymphoma. |
Timeline
- Start date
- 2020-01-30
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
- First posted
- 2019-10-16
- Last updated
- 2020-03-18
Locations
2 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04127916. Inclusion in this directory is not an endorsement.