Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT00133367
Status:
COMPLETED
Last Update Posted:
2016-07-25
First Post:
2005-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D000961', 'term': 'Antilymphocyte Serum'}, {'id': 'C512542', 'term': 'thymoglobulin'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D008558', 'term': 'Melphalan'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D007106', 'term': 'Immune Sera'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-22', 'studyFirstSubmitDate': '2005-08-19', 'studyFirstSubmitQcDate': '2005-08-22', 'lastUpdatePostDateStruct': {'date': '2016-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the effectiveness of tacrolimus and sirolimus in preventing graft versus host disease', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'To evaluate the days to neutrophil engraftment and platelet engraftment', 'timeFrame': '2 years'}, {'measure': 'To evaluate the relapse rate and overall disease free survival'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hematologic malignancy', 'Cord blood transfusion', 'Graft versus host disease', 'tacrolimus', 'sirolimus'], 'conditions': ['Multiple Myeloma', "Non-Hodgkin's Lymphoma", "Hodgkin's Disease", 'Myelogenous Leukemia', 'Lymphoblastic Leukemia']}, 'referencesModule': {'references': [{'pmid': '20107229', 'type': 'DERIVED', 'citation': 'Brown JA, Stevenson K, Kim HT, Cutler C, Ballen K, McDonough S, Reynolds C, Herrera M, Liney D, Ho V, Kao G, Armand P, Koreth J, Alyea E, McAfee S, Attar E, Dey B, Spitzer T, Soiffer R, Ritz J, Antin JH, Boussiotis VA. Clearance of CMV viremia and survival after double umbilical cord blood transplantation in adults depends on reconstitution of thymopoiesis. Blood. 2010 May 20;115(20):4111-9. doi: 10.1182/blood-2009-09-244145. Epub 2010 Jan 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure the effectiveness of 2 drugs, tacrolimus and sirolimus, in preventing graft versus host disease (GVHD) after treatment with chemotherapy followed by donor cord blood transplantation.', 'detailedDescription': "* The chemotherapy portion of the study involves the intravenous administration of fludarabine, for six days (Days 8, 7, 6, 5,4, and 3) before transplant, melphalan, for one day (Day 2) before transplant. Antithymocyte globulin, or thymoglobulin, will be given IV daily for 4 days (days 7, 5, 3, and 1 before transplant). This drug also helps to suppress the immune system, allowing the cord blood cells to grow and reproduce.\n* Immunosuppression therapy consists of the drugs tacrolimus and sirolimus. The patient will receive these 3 days before the transplant and every day for 3-6 months after transplant. After the first 100 days post transplant, the doses of tacrolimus and sirolimus will begin to be reduced with the goal of having the patient off both drugs by 6-9 months after transplant.\n* After completion of conditioning therapy described above, the patient will receive 2 cord blood units 1-6 hours apart. To help with engraftment, the patient will also receive G-CSF starting on day five after transplant, until the patients white blood cells recover.\n* Follow-up visits will continue every 6 months after the last treatment dose and will last up to 2 years.\n* Blood tests will be drawn frequently to test whether the donor's immune cells have engrafted as well as to test the levels of Tacrolimus and Sirolimus."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with hematologic malignancies for whom allogeneic stem cell transplantation is deemed clinically appropriate\n* Non-Hodgkin's lymphoma, or Hodgkin's lymphoma: in Complete Remission \\>2 (second complete remission, third complete remission, etc) or in partial remission\n* Multiple myeloma: relapsed\n* Chronic lymphocytic leukemia, Rai stage III or IV, or lymphocyte doubling time of 6 months, or stage I-II, having progressed after \\> 2 chemotherapy regimens, in partial remission.\n* Acute myelogenous or lymphoblastic leukemia in second or subsequent remission or in first remission with adverse cytogenetic or antecedent hematologic disorder\n* Chronic myelogenous leukemia in accelerated or second stable phase, or imatinib resistant and not eligible for an ablative transplant\n* Myelodysplasia, previously treated or not eligible for ablative transplant\n* Age 18-65 years.\n* ECOG performance status of 0, 1, or 2.\n* Lack of 6/6 or 5/6 HLA-matched related, 10/10 matched unrelated donor, or unrelated donor not available within the time frame necessary to perform a potentially curative stem cell transplant.\n\nExclusion Criteria:\n\n* Cardiac disease:\n\n * symptomatic congestive heart failure or\n * radionuclide ventriculogram (RVG) or echocardiogram determined left ventricular ejection fraction of \\< 40%,\n * active angina pectoris, or\n * uncontrolled hypertension.\n* Pulmonary disease:\n\n * severe chronic obstructive lung disease, or\n * symptomatic restrictive lung disease, or\n * corrected DLCO of \\< 50% of predicted.\n* Renal disease:\n\n * serum creatinine \\> 2.0 mg/dl.\n* Hepatic disease:\n\n * serum bilirubin \\> 2.0 mg/dl (except in the case of Gilbert's syndrome or hemolytic anemia in which the bilirubin can be elevated greater than 2.0mg/dl),\n * SGOT or SGPT \\> 3 x normal.\n* Neurologic disease:\n\n * symptomatic leukoencephalopathy,\n * active central nervous system (CNS) malignancy or other neuropsychiatric abnormalities believed to preclude transplantation (previous CNS malignancy, presently in complete remission \\[CR\\] is not exclusion).\n* HIV antibody.\n* Uncontrolled infection.\n* Pregnancy or breast feeding mother."}, 'identificationModule': {'nctId': 'NCT00133367', 'briefTitle': 'Study of Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Phase II Study of Sequential Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus as Graft Versus Host Disease Prophylaxis', 'orgStudyIdInfo': {'id': '05-154'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tacrolimus', 'type': 'DRUG', 'description': 'Given three days before transplant and every day for 3-6 months after transplant. After first 100 days post-transplant, the dose will be reduced.'}, {'name': 'Sirolimus', 'type': 'DRUG', 'description': 'Given three days before transplant and every day for 3-6 months after transplant. After first 100 days post-transplant, the dose will be reduced.'}, {'name': 'G-CSF', 'type': 'DRUG', 'description': 'Given starting on day 5 after transplant until the subjects white blood cell count recovers.'}, {'name': 'Antithymocyte globulin', 'type': 'DRUG', 'description': 'Given intravenously for 4 days before transplant (days 7, 5, 3, 1).'}, {'name': 'Thymoglobulin', 'type': 'DRUG', 'description': 'Given intravenously for 4 days before transplant (days 7, 5, 3, 1).'}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Given intravenously for six days prior to transplant (days 8,7,6,5,4,3).'}, {'name': 'Melphalan', 'type': 'DRUG', 'description': 'Given intravenously on day 2 before transplant.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Karen K Ballen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Karen Ballen', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}