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Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma (MCLRR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04061850
Recruitment Status : Active, not recruiting
First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Won Seog Kim, Samsung Medical Center

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

Condition or disease
Mantle Cell Lymphoma

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma: Multicenter Retrospective Analysis
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Aged ≥ 19 years, relapsed or refractory patients treated with ibrutinib, including relapse after autologous stem cell transplantation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04061850


Locations
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Korea, Republic of
81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Won Seog Kim, Professor Samsung Medical Center

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Responsible Party: Won Seog Kim, MD, Ph.D, Professor of Hematology-Oncology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT04061850     History of Changes
Other Study ID Numbers: SMC 2019-04-142
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin