Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-05 @ 6:37 PM
Study NCT ID:
NCT04852692
Status:
TERMINATED
Last Update Posted:
2025-05-23
First Post:
2021-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Comparative Effectiveness of Ibrutinib in Steroid Dependent/Refractory cGVHD Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "After conducting pilot phase, the study team decided to stop the study as the study couldn't meet the study target number of patients and study objectives.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2021-04-16', 'studyFirstSubmitQcDate': '2021-04-16', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A and Part B: Percentage of Participants with Overall Response Rate', 'timeFrame': 'Week 24', 'description': 'Overall response rate is defined as the percentage of participants who achieve complete response (CR) or partial response (PR) according to modified National Institutes of Health (NIH) response.'}], 'secondaryOutcomes': [{'measure': 'Part B: Rate of Sustained Response', 'timeFrame': 'At least 5 months (up to 36 weeks)', 'description': 'Sustained response rate will be assessed.'}, {'measure': 'Part B: Duration of Response', 'timeFrame': 'Up to 5 months', 'description': 'Duration of response will be assessed.'}, {'measure': 'Part A and Part B: Corticosteroid Requirement Changes Over Time', 'timeFrame': 'Up to 24 weeks', 'description': 'The change of the corticosteroid dose requirement during the treatment will be assessed.'}, {'measure': 'Part B: Time to cGVHD Progression', 'timeFrame': 'Up to 36 weeks', 'description': 'Time to chronic graft versus host disease (cGVHD) progression is defined as the time from the first dose of the ibrutinib to modified NIH response defined progression.'}, {'measure': 'Part B: Change in Lee cGVHD Symptom Scale', 'timeFrame': 'Up to 36 weeks', 'description': 'Change in Lee cGVHD symptom scale will be assessed. It is a participant reported improvement in symptom burden.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic', 'Ibrutinib', 'Retrospective', 'Prospective'], 'conditions': ['Chronic Graft vs Host Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of ibrutinib compared to conventional salvage treatments in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (modified National Institutes of Health \\[NIH\\] response defined complete response \\[CR\\] and partial response \\[PR\\]) at Week 24.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with steroid dependent or refractory chronic graft versus host disease (cGVHD) will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPart A and Part B\n\n* Must have a confirmed diagnosis of steroid dependent or refractory classic cGVHD defined at any time post-hematopoietic cell transplantation (HCT) as: a) refractory disease - progressive cGVHD manifestations requiring prednisolone at greater than or equal to (\\>=) 1 milligram per kilogram per day (mg/kg/day) for at least 1 week or persist without improvement despite continued treatment with glucocorticoid (prednisolone at \\>= 0.5 mg/kg/day or 1 mg/kg every other day) for at least 4 weeks; b) dependent disease: persistent cGVHD manifestations requiring glucocorticoid \\>= prednisolone 0.25 mg/kg/day or \\>=0.5mg/kg every other day for at least 8 weeks Part A\n* Treated at least 2 or more therapies for cGVHD (including glucocorticoids)\n* Participants whose identified last line of conventional salvage treatment is second-fourth line of therapy\n* Index date (initiation date of the identified last-line of conventional salvage therapy) at least 28 weeks before the study initiation date Part B\n* Treated at least 3 lines therapies for cGVHD (including glucocorticoids)\n* Participants who are treated with ibrutinib in their second-fourth line of therapy\n\nExclusion Criteria:\n\nPart A and Part B\n\n* Known or suspected active acute GVHD\n* Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 28 days Part A\n* Treated with an investigational agent for their identified last-line of conventional salvage therapy\n* Pregnant, breastfeeding during last-line of conventional salvage therapy Part B\n* Pregnant, breast-feeding, or of childbearing potential without a negative serum or urine pregnancy test within 7 days of enrollment. Male or female participants of childbearing potential unwilling to use effective contraceptive precautions throughout the trial'}, 'identificationModule': {'nctId': 'NCT04852692', 'briefTitle': 'A Study to Investigate the Comparative Effectiveness of Ibrutinib in Steroid Dependent/Refractory cGVHD Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Korea, Ltd., Korea'}, 'officialTitle': 'A Retrospective/Prospective, Multicenter, Non-interventional, Historical Control Study Investigating Comparative Effectiveness of IMBRUVICA in Steroid Dependent/Refractory cGVHD Patients', 'orgStudyIdInfo': {'id': 'CR108945'}, 'secondaryIdInfos': [{'id': '54179060GVH4001', 'type': 'OTHER', 'domain': 'Janssen Korea, Ltd., Korea'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Part A: Retrospective Phase', 'description': 'Retrospective collection of data for eligible participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) who initiated salvage treatments from initiation point (administration starting point of the salvage treatment) of the identified last-line of conventional salvage therapy for cGVHD treatment as their second-forth line therapy and will be collected for up to 24 weeks from the initiation point.'}, {'label': 'Part B: Prospective Phase', 'description': 'Prospectively enroll participants with steroid dependent/refractory cGVHD that are decided to be treated with ibrutinib in second-fourth line therapy for the treatment of cGVHD. Participants will continue to receive corticosteroids as a standard of care.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14584', 'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Soonchunhyang University Bucheon Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '41944', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04401', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Soonchunhyang University Seoul Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'The Catholic University of Korea Seoul St Mary s Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Janssen Korea, Ltd., Korea Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Korea, Ltd., Korea'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Korea, Ltd., Korea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}