Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma

Completed

• Conditions: Mantle Cell Lymphoma

• Registration Number: NCT04061850
• Lead Sponsor: Samsung Medical Center

Brief Summary

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 Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-08-14
• Study First Submitted QC: 2019-08-18
• Study First Posted: 2019-08-20
• Primary Completion: 2020-03-31
• Study Completion: 2020-08-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea; 🇰🇷 Seoul, Korea, Republic of