Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT00723333
Status:
COMPLETED
Last Update Posted:
2009-10-12
First Post:
2008-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bone Marrow Transplant Chart Review for RIC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055728', 'term': 'Primary Myelofibrosis'}], 'ancestors': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-08', 'studyFirstSubmitDate': '2008-07-24', 'studyFirstSubmitQcDate': '2008-07-25', 'lastUpdatePostDateStruct': {'date': '2009-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of engraftment rate, relapse rate, disease free survival, overall survival, causes of death and other pertinent statistics. Data will be compared to appropriate historical controls.', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bone Marrow Transplant', 'Myelofibrosis', 'Stem Cell Transplant', 'Allogenic Transplant'], 'conditions': ['Myelofibrosis']}, 'referencesModule': {'references': [{'pmid': '18024650', 'type': 'BACKGROUND', 'citation': 'Hoffman R, Rondelli D. Biology and treatment of primary myelofibrosis. Hematology Am Soc Hematol Educ Program. 2007:346-54. doi: 10.1182/asheducation-2007.1.346.'}, {'pmid': '10331505', 'type': 'BACKGROUND', 'citation': 'Mesa RA, Silverstein MN, Jacobsen SJ, Wollan PC, Tefferi A. Population-based incidence and survival figures in essential thrombocythemia and agnogenic myeloid metaplasia: an Olmsted County Study, 1976-1995. Am J Hematol. 1999 May;61(1):10-5. doi: 10.1002/(sici)1096-8652(199905)61:13.0.co;2-i.'}, {'pmid': '15671439', 'type': 'BACKGROUND', 'citation': 'Rondelli D, Barosi G, Bacigalupo A, Prchal JT, Popat U, Alessandrino EP, Spivak JL, Smith BD, Klingemann HG, Fruchtman S, Hoffman R; Myeloproliferative Diseases-Research Consortium. Allogeneic hematopoietic stem-cell transplantation with reduced-intensity conditioning in intermediate- or high-risk patients with myelofibrosis with myeloid metaplasia. Blood. 2005 May 15;105(10):4115-9. doi: 10.1182/blood-2004-11-4299. Epub 2005 Jan 25.'}]}, 'descriptionModule': {'briefSummary': 'We will evaluate the records of 30 patients that have undergone allogeneic transplant, specifically looking at engraftment rate, relapse rate, disease free survival, overall survival, causes of death and other pertinent statistics. We will compare the outcomes to appropriate historical controls.', 'detailedDescription': "Primary myelofibrosis (PMF) is among the Philadelphia Chromosome Negative Myeloproliferative Disorders. This diagnosis can be present at a patient's initial diagnosis or it can arise out of preceding Polycythemia Vera or Essential Thrombocythemia. While the clinical course is variable, it is defined by varying degrees of splenomegaly, anemia, fatigue and other constitutional symptoms. Patients with PMF are at increased risk of acute leukemia, bone marrow failure and thrombosis. Currently, the only curative treatment for PMF is allogeneic stem cell transplant. However, as the median age at diagnosis is in the mid to late 60s, most patients are no longer candidates for transplant due to their age and/or other comorbid illnesses.\n\nUnfortunately, all other treatments for PMF are palliative in nature and often of limited efficacy. Over the last several years, many advances have occurred that have increased the safety and improved the outcomes of allogeneic transplants. Perhaps most important has been the ongoing refinement of reduced intensity conditioning (RIC) regimens prior to transplant. Over the last few years, many groups have published data suggesting that these RIC transplants can be very effective in the treatment of PMF and it is felt to be a potentially curative procedure. However, the vast majority of these data are reported in persons younger than 65 years old. The current protocol for RIC transplant for PMF available at the University of Utah excludes patients older than the age of 65.\n\nWe would like to see if there is sufficient successful experience with transplant in persons older than 60 years old (including many older than 65 years of age) to justify the creation of a clinical trial using RIC regimens in this older age group. We will be reviewing the medical records of approximately 30 patients at four different institutions:\n\n* University of Utah/Huntsman Cancer Hospital\n* Fred Hutchinson Cancer Research Center\n* Baylor College of Medicine\n* M.D. Anderson Cancer Centers\n\nWe will evaluate: engraftment rate, relapse rate, disease free survival, overall survival, causes of death and other pertinent statistics. We will compare the outcomes to appropriate historical controls. We hypothesize that RIC regimens may be justifiably safe in older patients with PMF and hope that our data will allow the development of a corollary clinical trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients \\> 60 years of age with Primary Myelofibrosis that have undergone an allogeneic transplant', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 60 years of age\n* Diagnosed with Primary Myelofibrosis\n* Undergone Allogeneic Transplant\n\nExclusion Criteria:\n\n* Any subjects not meeting the criteria above'}, 'identificationModule': {'nctId': 'NCT00723333', 'briefTitle': 'Bone Marrow Transplant Chart Review for RIC', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Chart Review of Reduced Intensity Conditioning (RIC) Allogeneic Transplants in Elderly Patients With Myelofibrosis.', 'orgStudyIdInfo': {'id': '29021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Affected Group', 'description': 'Patients \\> 60 years of age with Primary Myelofibrosis that have undergone an allogeneic transplant', 'interventionNames': ['Procedure: Reduced Intensity Conditioning (RIC) Allogenic Transplant']}], 'interventions': [{'name': 'Reduced Intensity Conditioning (RIC) Allogenic Transplant', 'type': 'PROCEDURE', 'otherNames': ['Stem Cell Transplants', 'Bone Marrow Transplants', 'Mini Transplants'], 'description': 'Reduced Intensity Conditioning (RIC) Regimen Allogenic Stem Cell Transplant', 'armGroupLabels': ['Affected Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Centers', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Josef T Prchal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Josef T. Prchal, MD', 'oldOrganization': 'University of Utah'}}}}