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Completed

NCT Number: NCT04061850

Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea

Seoul, 06351, South Korea

About this study

# 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Acronym: MCLRR

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 20, 2019
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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