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

Mantle Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04127916
• Other study ID #: 2019-07-091
• Status: Recruiting
• Start date: January 30, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: Samsung Medical Center
• Contact: Kim wonseog, Professor
• Phone: 010-9933-5823
• Email: wonseog.kim[@]samsung.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate,	Overall response rate, including complete response and partial response	2020.12.30
Secondary	Progression-free survival	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
Secondary	Overall survival	The percentage of people in a study or treatment group still alive for a given period of time after diagnosis	2020.12.30
Secondary	Duration of response	Duration of response	2020.12.30
Secondary	Treatment-emergent adverse event	Treatment-emergent adverse event	2020.12.30
Secondary	Prognostic factor	Prognostic factor	2020.12.30