Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-26 @ 7:22 AM
Study NCT ID:
NCT04061850
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2019-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2019-08-14', 'studyFirstSubmitQcDate': '2019-08-18', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival period', 'timeFrame': 'Up to 3 years, From the date of diagnosis with MCL to the date of relapse/disease progression, or last follow-up date', 'description': 'Progression free survival period with ibrutinib'}], 'secondaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': 'Up to 3 years, From the date of diagnosis with MCL to the date of death, or last follow-up date', 'description': 'Overall response rate with ibrutinib'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mantle Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'To review the efficacy and the safety of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL).', 'detailedDescription': "\\# 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.\n\nIn 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Aged ≥ 19 years, relapsed or refractory patients treated with ibrutinib, including relapse after autologous stem cell transplantation', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with MCL diagnosed by a pathologist (based on the WHO 2017 classification)\n\n 1. mantle cell lymphoma\n 2. leukemic nonnodal mantle cell lymphoma\n 3. in situ mantle cell neoplasia\n* Aged ≥ 19 years\n* Relapsed or refractory patients treated with ibrutinib, including relapse after autologous stem cell transplantation\n\nExclusion Criteria:\n\n* Patients whose clinical and pathological data are not available\n* Patients who were not treated with ibrutinib'}, 'identificationModule': {'nctId': 'NCT04061850', 'acronym': 'MCLRR', 'briefTitle': 'Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma: Multicenter Retrospective Analysis', 'orgStudyIdInfo': {'id': 'SMC 2019-04-142'}}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': '81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Won Seog Kim, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Ph.D, Professor of Hematology-Oncology', 'investigatorFullName': 'Won Seog Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}