MCLRR: Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT04061850

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To review the efficacy and the safety of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL).

Condition or Disease	Intervention/Treatment	Phase
Mantle Cell Lymphoma

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

Study Type:

Observational

Actual Enrollment :

88 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma: Multicenter Retrospective Analysis

Actual Study Start Date :

Jul 1, 2019

Actual Primary Completion Date :

Mar 31, 2020

Actual Study Completion Date :

Aug 31, 2020

Outcome Measures

Primary Outcome Measures

Progression free survival period [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

Secondary Outcome Measures

Overall response rate [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

Patients whose clinical and pathological data are not available
Patients who were not treated with ibrutinib

Contacts and Locations

Locations

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

Sponsors and Collaborators

Samsung Medical Center

Investigators

Principal Investigator: Won Seog Kim, Professor, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Won Seog Kim, MD, Ph.D, Professor of Hematology-Oncology, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT04061850

Other Study ID Numbers:

SMC 2019-04-142

First Posted:

Aug 20, 2019

Last Update Posted:

Oct 22, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lymphoma

Lymphoma, Mantle-Cell

Study Results

No Results Posted as of Oct 22, 2020