Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-03-08 @ 12:26 AM
Study NCT ID:
NCT01383434
Status:
TERMINATED
Last Update Posted:
2016-10-13
First Post:
2011-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Marrow Transplant Trial for Patients With Refractory Severe Aplastic Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000741', 'term': 'Anemia, Aplastic'}], 'ancestors': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000080983', 'term': 'Bone Marrow Failure Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016026', 'term': 'Bone Marrow Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'New revised SAA BMT study opened to take over this study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-12', 'studyFirstSubmitDate': '2011-06-22', 'studyFirstSubmitQcDate': '2011-06-27', 'lastUpdatePostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To estimate the overall survival (OS) at 1 year following HLA-matched, Partially HLA-mismatched, HLA-haploidentical or matched unrelated Bone Marrow for Patients with Refractory Severe Aplastic Anemia', 'timeFrame': '1 year'}, {'measure': 'To estimate the event-free survival (EFS) at 1 year following HLA-matched, Partially HLA-mismatched, HLA-haploidentical or matched unrelated Bone Marrow for Patients with Refractory Severe Aplastic Anemia', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Severe Aplastic Anemia']}, 'descriptionModule': {'briefSummary': 'Patients with severe, refractory aplastic anemia have a severe, life threatening disease in their bone marrow. Refractory disease means that disease has come back or not responded after receiving one or more immunosuppressive treatments. High dose chemotherapy followed by bone marrow transplantation (BMT) has been used to treat blood diseases like aplastic anemia but complications from Graft vs Host disease (GVHD) and graft failure have limited the survival for those patients.\n\nAnother study done here at Johns Hopkins has shown that in patients with other diseases (blood cancers) some immunosuppressive drugs given after the BMT has decreased how often patients had complications of GVHD and engraftment failure.\n\nThis research is being done to find if this approach will help patients with aplastic anemia who have failed other treatments will have better outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have refractory or relapsed SAA following treatment with one or more immunosuppressive regimens.\n* Age 6 months - 70 years\n* Patients must meet medical criteria for myeloablative BMT\n* Patients or their parents/guardians and donors must be able to sign consent forms.\n* Patients must be geographically accessible and willing to participate in all stages of treatment.\n\nExclusion Criteria:\n\n* Poor cardiac function: left ventricular ejection fraction \\<45% as determined by MUGA or ECHO.\n* Poor pulmonary function: FEV1 and FVC \\<50% predicted.\n* Poor renal function\n* Positive leukocytotoxic crossmatch\n* Women of childbearing potential who currently are pregnant (Β-HCG+) or who are not practicing adequate contraception\n* Uncontrolled viral, bacterial, or fungal infections'}, 'identificationModule': {'nctId': 'NCT01383434', 'briefTitle': 'Bone Marrow Transplant Trial for Patients With Refractory Severe Aplastic Anemia', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'A Phase II Trial of Myeloablative Conditioning and Transplantation of HLA-matched, Partially HLA-mismatched, HLA-haploidentical or Matched Unrelated (MUD) Bone Marrow for Patients With Refractory Severe Aplastic Anemia', 'orgStudyIdInfo': {'id': 'J10117'}, 'secondaryIdInfos': [{'id': 'NA_00042991', 'type': 'OTHER', 'domain': 'The Johns Hopkins University'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Bone Marrow Transplant', 'type': 'PROCEDURE', 'description': 'Matched sibling, haploidentical or matched unrelated donor bone marrow transplant following chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21031', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Sidney Kimmel Comprehensive Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Robert A Brodsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Johns Hopkins University'}, {'name': 'Amy Dezern, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The JOhns Hopkins Sydney Kimmel Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}