Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma (MCLRR)
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|ClinicalTrials.gov Identifier: NCT04061850|
Recruitment Status : Active, not recruiting
First Posted : August 20, 2019
Last Update Posted : August 20, 2019
|Condition or disease|
|Mantle Cell Lymphoma|
# 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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma: Multicenter Retrospective Analysis|
|Actual Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||February 28, 2020|
- 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
- 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 ]Overall response rate with ibrutinib
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04061850
|Korea, Republic of|
|81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea|
|Seoul, Korea, Republic of, 06351|
|Principal Investigator:||Won Seog Kim, Professor||Samsung Medical Center|