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

Last updated: March 16, 2020
Sponsor: Samsung Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mantle Cell Lymphoma

Lymphoma

Lymphoproliferative Disorders

Treatment

N/A

Clinical Study ID

NCT04127916
2019-07-091
  • Ages > 19
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 receivedbendamustine + rituximab as initial therapy and patients who receivedbendamustine + rituximab for the treatment of relapsed/refractory condition areboth included.

Exclusion

Exclusion Criteria:

    1. Patients whose clinical and pathological data are not available 2. Patients whowere not treated with a combination of bendamustine and rituximab

Study Design

Total Participants: 40
Study Start date:
January 30, 2020
Estimated Completion Date:
December 31, 2020

Study 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.

  4. Exclusion criteria :

  5. Patients whose clinical and pathological data are not available

  6. 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.

Connect with a study center

  • Samsung Medical Center, 81 Irwon-ro, Gangnam-gu, Seoul, Republic of Korea

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center, 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea

    Seoul, 06351
    Korea, Republic of

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.