Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma

NCT02169180

Lymphoma, Mantle-cell

COMPLETED PHASE2

A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell Lymphoma

NCT05564052

Lymphoma, Mantle-Cell

COMPLETED PHASE2

Ibrutinib and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or Older Patients With Newly Diagnosed Mantle Cell Lymphoma

NCT01880567

CCND1 Positive CCND2 Positive CCND3 Positive +4 more

ACTIVE_NOT_RECRUITING PHASE2

Ibrutinib Combined With R-CHOP/R-DHAP in Newly Diagnosed Mantle Cell Lymphoma Patients Who Aged ≤65 Years

NCT05429918

Mantle Cell Lymphoma

UNKNOWN

An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

NCT01833039

Relapsed or Refractory Mantle Cell Lymphoma

APPROVED_FOR_MARKETING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

\# 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mantle Cell Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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