Clinical trial NCT04127916: Bendamustine Plus Rituximab for Mantle Cell Lymphoma: a Multicenter Retrospective Analysis(BR-MCL)
Official title: Bendamustine Plus Rituximab for Mantle Cell Lymphoma: a Multicenter Retrospective Analysis(BR-MCL)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mantle Cell Lymphoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall response rate,
timeFrame: 2020.12.30
Secondary outcomes:
measure: Progression-free survival
timeFrame: 2020.12.30
measure: Overall survival
timeFrame: 2020.12.30
measure: Duration of response
timeFrame: 2020.12.30
measure: Treatment-emergent adverse event
timeFrame: 2020.12.30
measure: Prognostic factor
timeFrame: 2020.12.30
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, 81 Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
Study officials:
affiliation: Samsung Medical Center
name: Kim wonseog, Professor
role: PRINCIPAL_INVESTIGATOR
References: