Mantle Cell LymphomaNCT04127916
Bendamustine Plus Rituximab for Mantle Cell Lymphoma: a Multicenter Retrospective Analysis(BR-MCL)
An observational study of Mantle Cell Lymphoma, run by Samsung Medical Center at 2 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Bendamustine
- How many people
- 40 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 30 Jan 2020to 31 Dec 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 1. Patients newly diagnosed with mantle cell lymphoma by a pathologist (based on the 2016 revision of the WHO classification)
- mantle cell lymphoma
- leukemic non-nodal mantle cell lymphoma
- 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.
Who cannot join
- 1. Patients whose clinical and pathological data are not available 2. Patients who were not treated with a combination of bendamustine and rituximab
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Samsung Medical Center, 81 Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
Seoul, 06351
Kim Wonseog, Professor, 010-9933-5823, wonseog.kim@samsung.com
Hyeseon Jeon, CRA, +82-70-7014-4169, hyeseon84.jeon@samsung.com
- Not yet recruiting
Samsung Medical Center, 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
Seoul, 06351
Kim Wonseog, Professor, 010-9933-5823, wonseog.kim@samsung.com
Hyeseon Jeon, CRA, +82-70-7014-4169, hyeseon84.jeon@samsung.com
About this study
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.
Read the detailed description
- 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
- Age ≥ 19 years
- 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 :
- Patients whose clinical and pathological data are not available
- 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
- Mantle Cell Lymphoma
- Being tested
- Bendamustine
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustineDrug
Also called Rituximab
To investigate the efficacy and safety of bendamustine plus rituximab in patients with mantle cell lymphoma.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate,
Overall response rate, including complete response and partial response
Measured: 2020.12.30
Secondary outcomes (5)
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
Measured: 2020.12.30
Overall survival
The percentage of people in a study or treatment group still alive for a given period of time after diagnosis
Measured: 2020.12.30
Duration of response
Duration of response
Measured: 2020.12.30
Treatment-emergent adverse event
Treatment-emergent adverse event
Measured: 2020.12.30
Prognostic factor
Prognostic factor
Measured: 2020.12.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start30 Jan 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Seog Kim, Samsung Medical Center
- Investigators
- Kim wonseog, Professor, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127916
- Sponsor's protocol ID
- 2019-07-091
- Status last verified
- Mar 2020
- First submitted
- 13 Oct 2019
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no IPD sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bendamustine Plus Rituximab for Mantle Cell Lymphoma: a Multicenter Retrospective Analysis(BR-MCL)
- ClinicalTrials.gov ID
- NCT04127916
- Acronym / sponsor ID
- 2019-07-091
- Conditions
- Mantle Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Age ≥ 19 years
- 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 :
- Patients whose clinical and pathological data are not available
- 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
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 1. Patients newly diagnosed with mantle cell lymphoma by a pathologist (based on the 2016 revision of the WHO classification)
Key exclusion criteria (1 listed)
- 1. Patients whose clinical and pathological data are not available 2. Patients who were not treated with a combination of bendamustine and rituximab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BendamustineAlso: RituximabTo investigate the efficacy and safety of bendamustine plus rituximab in patients with mantle cell lymphoma. | Drug | – |
Primary outcome
Overall response rate,
Time frame: 2020.12.30
Overall response rate, including complete response and partial response
5 secondary outcomes
Progression-free survival
Time frame: 2020.12.30
Overall survival
Time frame: 2020.12.30
Duration of response
Time frame: 2020.12.30
Treatment-emergent adverse event
Time frame: 2020.12.30
Prognostic factor
Time frame: 2020.12.30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: No. There is no IPD sharing plan
Related trials for Mantle Cell Lymphoma
Not yet recruitingPhase 2
Polatuzumab Vedotin, Mosunetuzumab, and Acalabrutinib for the Treatment of Mantle Cell Lymphoma, PAcMan Trial
Mantle Cell Lymphoma
RecruitingPhase 2
Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy
Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma
RecruitingPhase 1
A Study of ARC-02 in B-cell NHL
B-cell Non Hodgkin Lymphoma
Active, not recruitingPhase 2
GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma
Mantle Cell Lymphoma
RecruitingPhase 2
Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma
Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim wonseog, Professor principal investigator
Samsung Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mantle Cell Lymphoma, run by Samsung Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim wonseog, Professor (010-9933-5823 ext. +82, wonseog.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate, (time frame: 2020.12.30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.