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

NCT ID: NCT04127916

Last Updated: 2020-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-30

Study Completion Date

2020-12-31

Brief Summary

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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

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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

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Mantle Cell Lymphoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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Bendamustine

To investigate the efficacy and safety of bendamustine plus rituximab in patients with mantle cell lymphoma.

Intervention Type DRUG

Other Intervention Names

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Rituximab

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Won Seog Kim

MD,phD,Division of hematology, Department of medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kim wonseog, Professor

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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

Seoul, , South Korea

Site Status RECRUITING

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

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Countries

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South Korea

Central Contacts

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Kim wonseog, Professor

Role: CONTACT

010-9933-5823 ext. +82

Kim seokjin

Role: CONTACT

010-9933-1766 ext. +82

Facility Contacts

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Kim Wonseog, Professor

Role: primary

010-9933-5823

Hyeseon Jeon, CRA

Role: backup

+82-70-7014-4169

Kim Wonseog, Professor

Role: primary

010-9933-5823

Hyeseon Jeon, CRA

Role: backup

+82-70-7014-4169

Other Identifiers

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2019-07-091

Identifier Type: -

Identifier Source: org_study_id

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