Bendamustine Plus Rituximab for Mantle Cell Lymphoma: a Multicenter Retrospective Analysis(BR-MCL)

• Conditions: Mantle Cell Lymphoma

• Registration Number: NCT04127916
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study First Submitted: 2019-10-13
• Study First Submitted QC: 2019-10-13
• Study First Posted: 2019-10-16
• Study Start: 2020-01-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1. Patients newly diagnosed with mantle cell lymphoma by a pathologist (based on the 2016 revision of the WHO classification)

  2. mantle cell lymphoma

  3. leukemic non-nodal mantle cell lymphoma

  4. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall response rate,	2020.12.30	Overall response rate, including complete response and partial response

Secondary Outcome Measures

Name	Time	Method
Duration of response	2020.12.30	Duration of response
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
Treatment-emergent adverse event	2020.12.30	Treatment-emergent adverse event
Prognostic factor	2020.12.30	Prognostic factor
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

Trial Locations

Locations (2)

Samsung Medical Center, 81 Irwon-ro, Gangnam-gu, Seoul, Republic of Korea; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center, 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea; 🇰🇷 Seoul, Korea, Republic of