Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-25 @ 1:13 PM
Study NCT ID:
NCT04398459
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-25
First Post:
2020-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000744', 'term': 'Anemia, Hemolytic, Autoimmune'}], 'ancestors': [{'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C551803', 'term': 'ibrutinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2020-05-18', 'studyFirstSubmitQcDate': '2020-05-18', 'lastUpdatePostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': 'within 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events and severe adverse events', 'timeFrame': 'within 48 weeks'}, {'measure': 'Relapse free survival rate', 'timeFrame': 'within 48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ibrutinib', 'BTK Inhibitor', 'autoimmune hemolytic anemia', 'AIHA'], 'conditions': ['Refractory/Relapsed Autoimmune Hemolytic Anemia']}, 'referencesModule': {'references': [{'pmid': '32536139', 'type': 'BACKGROUND', 'citation': 'Fang LW, Pan H, Shi J. [Ibrutinib treatment for 2 cases of relapsed/refractory autoimmune hemolytic anemia: a pilot study]. Zhonghua Xue Ye Xue Za Zhi. 2020 May 14;41(5):412-416. doi: 10.3760/cma.j.issn.0253-2727.2020.05.009. Chinese.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label, single-arm study to evaluate the safety and efficacy of Ibrutinib in subjects with refractory/relapsed autoimmune hemolytic anemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ECOG ≤ 3\n* Age from 6 to 70.\n* Diagnosed with WAIHA or MAIHA.\n* Meets the criteria of relapsed / refractory AIHA.\n* Meets the criteria of DAT-negative AIHA without any other inherited or acquired hemolytic diseases, and previously treated effectively with glucocorticoids and rituximab.\n* Signed informed consent.\n* Organs in good function.\n\nExclusion Criteria:\n\n* Nursing woman\n* Active bacterial, virus, fungal or parasitic infection, including HIV infection, HbsAg and HBV DNA positive, HCV DNA positive, etc.\n* Diagnosed with cold agglutinin disease or cold agglutinin syndrome or paroxysmal cold hemoglobinuria.\n* Secondary AIHA caused by drugs or infection.\n* Received rituximab in 8 weeks before enrollment.\n* Previously received treatment with BTK inhibitor.\n* Previously received organ or stem cell transplantation.\n* Have a history of thrombosis or organ infarction.\n* Diagnosed with an active stage of connective tissue disease.\n* Have a history of lymphoproliferative tumors or any other malignant tumors.\n* Have other inherited or acquired hemolytic diseases.\n* Received low-molecular-weight heparin or warfarin within 1 week before enrollment or during the Ibrutinib treatment.\n* Received CYP3A4 Enzyme Inhibitors or Inducers within 1 week before enrollment or during the Ibrutinib treatment.\n* Have a history of mental illness.\n* Inability to understand or to follow study procedures.'}, 'identificationModule': {'nctId': 'NCT04398459', 'briefTitle': 'The Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Hematology & Blood Diseases Hospital, China'}, 'officialTitle': 'A Phase II, Multicenter, Open-label Trial to Determine the Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic', 'orgStudyIdInfo': {'id': 'IIT2020005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iBRIAN', 'interventionNames': ['Drug: Ibrutinib']}], 'interventions': [{'name': 'Ibrutinib', 'type': 'DRUG', 'otherNames': ['BTK inhibitor'], 'description': 'Each recruited subject will accept Ibrutinib treatment.', 'armGroupLabels': ['iBRIAN']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhoukou', 'state': 'Henan', 'country': 'China', 'facility': 'Zhoukou Central Hospital', 'geoPoint': {'lat': 33.63333, 'lon': 114.63333}}, {'city': 'Tai’an', 'state': 'Shandong', 'country': 'China', 'facility': 'The Second Affilated Hospital of Shandong First Medical University', 'geoPoint': {'lat': 36.18528, 'lon': 117.12}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Regenerative Medicine Center', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Regenerative Medicine Clinic Center', 'investigatorFullName': 'Jun Shi', 'investigatorAffiliation': 'Institute of Hematology & Blood Diseases Hospital, China'}}}}