Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT00299767
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2006-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Study of Sequential Cord Blood Transplants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'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'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-09', 'studyFirstSubmitDate': '2006-03-03', 'studyFirstSubmitQcDate': '2006-03-03', 'lastUpdatePostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the 100-day transplant-related (non-relapse) mortality, including relapse-related mortality associated with Grade 4 toxicity.', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'To evaluate the 6 month transplant related (non-relapse) mortality.', 'timeFrame': '3 years'}, {'measure': 'To evaluate the days to neutrophil engraftment (ANC > 500).', 'timeFrame': '3 years'}, {'measure': 'To evaluate the days of platelet engraftment (platelet count > 20K unsupported).', 'timeFrame': '3 years'}, {'measure': 'To evaluate the risk of acute and chronic graft versus host disease.', 'timeFrame': '3 years'}, {'measure': 'To evaluate percent donor chimerism - contribution of each cord unit.', 'timeFrame': '3 years'}, {'measure': 'To evaluate relapse rate.'}, {'measure': 'To evaluate overall survival.'}, {'measure': 'To evaluate transfusion support needed to cord blood transplant recipients.', 'timeFrame': '3 years'}]}, 'conditionsModule': {'conditions': ['Lymphoma', 'Leukemia', 'Multiple Myeloma', 'Myelodysplastic Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety of sequential cord blood transplantation (2 cord blood units) for patients who have diseases that are capable of being cured by allogeneic stem cell transplant but do not have a matched family or volunteer unrelated donor.', 'detailedDescription': 'Eligible patients will receive conditioning therapy with fludarabine 30 mg/m2/day x 6 days, melphalan 100 mg/m2/day x 1 day, rabbit antithymocyte globulin 1.5 mg/kg/day x 4 days. GVHD prophylaxis will consist of cyclosporine starting on day -1 and mycophenolate mofetil starting on day 0. Sequential cord blood units will be infused on Day 0.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Disease Status: NHL, HD, or MM refractory to chemotherapy or relapsed; CLL Rai Stage III/IV, or lymphocyte doubling time of 6 months, or Stage I/II resistant to 2 chemotherapy regimens; AML or ALL in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder\n* Estimated disease-free survival of less than one year\n* ECOG performance status of 0, 1, 2\n* Lack of 6/6 or 5/6 HLA matched related or 6/6 matched unrelated donor, or a donor is not available within the time frame necessary to perform a potentially curative stem cell transplant\n* 4/6 or greater HLA A, B, CRB1 cord blood units with a combined nucleated cell dose from of \\> 3.7 x 10(7) NC/kg\n\nExclusion Criteria:\n\n* Cardiac disease: symptomatic congestive hearth failure or RVG or echocardiogram determined left ventricular ejection fraction of \\< 45%, active angina pectoris, or uncontrolled hypertension\n* Pulmonary Disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected DLCO of \\< 50%\n* Renal disease: serum creatinine \\> 2.0 mg/dl\n* Hepatic disease: serum bilirubin \\> 2.0 mg/dl (except in the case of Gilbert's syndrome), SGPT or SGOT \\> 3 x normal\n* Neurologic disease: symptomatic leukoencephalopathy, active DNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation\n* HIV antibody or Hepatitis B surface antigen positivity\n* Uncontrolled infection\n* Pregnancy or breast-feeding mother"}, 'identificationModule': {'nctId': 'NCT00299767', 'briefTitle': 'Phase I Study of Sequential Cord Blood Transplants', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Phase I Study of Sequential Cord Blood Transplants', 'orgStudyIdInfo': {'id': '03-061'}}, 'armsInterventionsModule': {'interventions': [{'name': 'sequential cord blood transplantation', 'type': 'PROCEDURE', 'description': 'Infused on Day 0'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02116', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Karen Ballen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital, Harvard University'}, {'name': 'Joseph Antin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana Farber Cancer Institute, Harvard Univeristy'}, {'name': 'David Avigan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Leukemia Program', 'investigatorFullName': 'Karen Ballen', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}