Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma

Mantle Cell Lymphoma Clinical Trial

— MCLRR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04061850
• Other study ID #: SMC 2019-04-142
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: October 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 31, 2020
• Est. primary completion date: March 31, 2020
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients with MCL diagnosed by a pathologist (based on the WHO 2017 classification)

1. mantle cell lymphoma

2. leukemic nonnodal mantle cell lymphoma

3. 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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Locations

Country	Name	City	State
Korea, Republic of	81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival period	Progression free survival period with ibrutinib	Up to 3 years, From the date of diagnosis with MCL to the date of relapse/disease progression, or last follow-up date
Secondary	Overall response rate	Overall response rate with ibrutinib	Up to 3 years, From the date of diagnosis with MCL to the date of death, or last follow-up date