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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04127916
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Anticipated Duration (Months): 11
• Patients Per Site: 20
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mantle Cell Lymphoma	Drug: Bendamustine

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.

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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 40 participants
• Observational Model: Case-Only
• Time Perspective: Other
• Official Title: Bendamustine Plus Rituximab for Mantle Cell Lymphoma: a Multicenter Retrospective Analysis(BR-MCL)
• Actual Study Start Date: Jan 30, 2020
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Outcome Measures

Primary Outcome Measures

1. Overall response rate, [2020.12.30]

   Overall response rate, including complete response and partial response

Secondary Outcome Measures

1. 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

2. 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

3. Duration of response [2020.12.30]

   Duration of response

4. Treatment-emergent adverse event [2020.12.30]

   Treatment-emergent adverse event

5. Prognostic factor [2020.12.30]

   Prognostic factor

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center, 81 Irwon-ro, Gangnam-gu, Seoul, Republic of Korea	Seoul		Korea, Republic of	06351
2	Samsung Medical Center, 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea	Seoul		Korea, Republic of	06351

Sponsors and Collaborators

• Samsung Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Won Seog Kim, MD,phD,Division of hematology, Department of medicine, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT04127916
• Other Study ID Numbers: 2019-07-091
• First Posted: Oct 16, 2019
• Last Update Posted: Mar 18, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Mantle-Cell; Bendamustine Hydrochloride

Study Results

No Results Posted as of Mar 18, 2020