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

March 16, 2020 updated by: Won Seog Kim, Samsung Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center, 81 Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
        • Contact:
        • Contact:
      • Seoul, Korea, Republic of, 06351
        • Not yet recruiting
        • Samsung Medical Center, 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate,
Time Frame: 2020.12.30
Overall response rate, including complete response and partial response
2020.12.30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 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
2020.12.30
Overall survival
Time Frame: 2020.12.30
The percentage of people in a study or treatment group still alive for a given period of time after diagnosis
2020.12.30
Duration of response
Time Frame: 2020.12.30
Duration of response
2020.12.30
Treatment-emergent adverse event
Time Frame: 2020.12.30
Treatment-emergent adverse event
2020.12.30
Prognostic factor
Time Frame: 2020.12.30
Prognostic factor
2020.12.30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Kim wonseog, Professor, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 30, 2020

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

October 13, 2019

First Submitted That Met QC Criteria

October 13, 2019

First Posted (ACTUAL)

October 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-07-091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no IPD sharing plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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