Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma (MCLRR)

Samsung Medical Center

Status: Completed

Conditions: Mantle Cell Lymphoma

Study type: Observational

Funder types: Other

Identifiers

NCT04061850

SMC 2019-04-142

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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