Mantle Cell LymphomaMCLRRNCT04061850
Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma
An observational study of Mantle Cell Lymphoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To review the efficacy and the safety of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2019to 31 Aug 2020
- 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
- Adult, Older adult
Study population: Aged ≥ 19 years, relapsed or refractory patients treated with ibrutinib, including relapse after autologous stem cell transplantation
Who may be able to join
- Patients with MCL diagnosed by a pathologist (based on the WHO 2017 classification)
- mantle cell lymphoma
- leukemic nonnodal mantle cell lymphoma
- in situ mantle cell neoplasia
- Aged ≥ 19 years
- Relapsed or refractory patients treated with ibrutinib, including relapse after autologous stem cell transplantation
Who cannot join
- Patients whose clinical and pathological data are not available
- Patients who were not treated with ibrutinib
Trial locations and contacts
1 site in 1 country.
South Korea1 site
81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
Seoul, 06351
About this study
Official title: Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma: Multicenter Retrospective Analysis
To review the efficacy and the safety of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL).
Read the detailed description
# Background and Rationale Mantle cell lymphoma (MCL) is a rare subtype of lymphoma, accounting for about 3-6% of all non-Hodgkin's lymphoma. It is clinically prevalent in the elderly and men, commonly with gastrointestinal tract involvement. Since about 80% of patients present with advanced stage disease at diagnosis, the prognosis is very poor. Mantle cell lymphoma is less frequent in Korean than in Western countries, accounting for about 2% of all non-Hodgkin's lymphoma cases, with very poor treatment outcome as Western countries.
In Korea, the clinical information about patients with MCL is very scarce so far and does not reflect recent treatment patterns. Firstly, the incidence in Korea is relatively lower than that in Western countries, with only about 100 patients a year. Secondly, due to substandard national health insurance regulations in Korea, it was not until recently that ibrutinib for relapsed/refractory MCL was approved for coverage by the National Health Insurance. In this context, the study was designed to investigate the efficacy and safety of ibrutinib in patients with relapsed or refractory MCL in Korea.
- Conditions
- Mantle Cell Lymphoma
- Medical subject headings
- Lymphoma, Mantle-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival period
Progression free survival period with ibrutinib
Measured: Up to 3 years, From the date of diagnosis with MCL to the date of relapse/disease progression, or last follow-up date
Secondary outcomes (1)
Overall response rate
Overall response rate with ibrutinib
Measured: Up to 3 years, From the date of diagnosis with MCL to the date of death, or last follow-up date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start1 Jul 2019
- Primary completion31 Mar 2020
- Study completion31 Aug 2020
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 88 participants (actual)
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
- Won Seog Kim, Professor, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061850
- Sponsor's protocol ID
- SMC 2019-04-142
- Acronym
- MCLRR
- Status last verified
- Oct 2020
- First submitted
- 14 Aug 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma: Multicenter Retrospective Analysis
- ClinicalTrials.gov ID
- NCT04061850
- Acronym / sponsor ID
- MCLRR / SMC 2019-04-142
- Conditions
- Mantle Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 20 Aug 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.
To review the efficacy and the safety of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL).
Detailed description
# Background and Rationale Mantle cell lymphoma (MCL) is a rare subtype of lymphoma, accounting for about 3-6% of all non-Hodgkin's lymphoma. It is clinically prevalent in the elderly and men, commonly with gastrointestinal tract involvement. Since about 80% of patients present with advanced stage disease at diagnosis, the prognosis is very poor. Mantle cell lymphoma is less frequent in Korean than in Western countries, accounting for about 2% of all non-Hodgkin's lymphoma cases, with very poor treatment outcome as Western countries.
In Korea, the clinical information about patients with MCL is very scarce so far and does not reflect recent treatment patterns. Firstly, the incidence in Korea is relatively lower than that in Western countries, with only about 100 patients a year. Secondly, due to substandard national health insurance regulations in Korea, it was not until recently that ibrutinib for relapsed/refractory MCL was approved for coverage by the National Health Insurance. In this context, the study was designed to investigate the efficacy and safety of ibrutinib in patients with relapsed or refractory MCL in Korea.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Aged ≥ 19 years, relapsed or refractory patients treated with ibrutinib, including relapse after autologous stem cell transplantation
Key inclusion criteria (6 listed)
- Patients with MCL diagnosed by a pathologist (based on the WHO 2017 classification)
- Aged ≥ 19 years
- Relapsed or refractory patients treated with ibrutinib, including relapse after autologous stem cell transplantation
Key exclusion criteria (2 listed)
- Patients whose clinical and pathological data are not available
- Patients who were not treated with ibrutinib
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression free survival period
Time frame: Up to 3 years, From the date of diagnosis with MCL to the date of relapse/disease progression, or last follow-up date
Progression free survival period with ibrutinib
1 secondary outcome
Overall response rate
Time frame: Up to 3 years, From the date of diagnosis with MCL to the date of death, or last follow-up date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Study to Evaluate the Safety and Preliminary Efficacy of Ibrutinib and Pembrolizumab in Patients With Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)
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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.
Won Seog Kim, Professor principal investigator
Samsung Medical Center
1 site 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 1 site 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival period (time frame: Up to 3 years, From the date of diagnosis with MCL to the date of relapse/disease progression, or last follow-up date). 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 22 Oct 2020.