Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-28 @ 4:34 PM
Study NCT ID:
NCT02386332
Status:
UNKNOWN
Last Update Posted:
2015-03-11
First Post:
2015-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Multicenter Study to Compare Two Types of Transplant in Adult Patients With Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014180', 'term': 'Transplantation'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 206}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-05', 'studyFirstSubmitDate': '2015-02-26', 'studyFirstSubmitQcDate': '2015-03-05', 'lastUpdatePostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-Free Survival (DFS)', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hematologic Malignancies']}, 'descriptionModule': {'briefSummary': 'This is an open-label, prospective, observational, multicenter, randomized study to compare the efficacy between unrelated umbilical cord blood transplantation (UCBT) and HLA-haploidentical related hematopoietic stem cell transplantation ,after myeloablative conditioning for adult patients with hematologic malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosed with acute leukemia or myelodysplastic syndrome in which allogeneic transplantation is considered the most potentially curative therapeutic option', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: subjects ≥ 18 and ≤ 55 years old.\n2. Patients without suitable matched related donor\n3. Diagnosed with acute leukemia or myelodysplastic syndrome in which allogeneic transplantation is considered the most potentially curative therapeutic option.\n4. Written consent form signed.\n\nExclusion Criteria:\n\n* Performance status: Eastern Cooperative Oncology Group(ECOG) score \\>2\n* Prior allogenic hematopoietic stem cell transplant\n* Left-ventricular ejection fraction at rest \\< 45%, uncontrolled arrhythmias or symptomatic heart failure.\n* Diffusing capacity (DLCO) and/or forced vital capacity (FVC) \\< 39% of predicted values or symptomatic pulmonary disease\n* Altered liver function tests (total bilirubin \\> 2 mg/dL and/or alanine aminotransferase, aspartate aminotransferase , and or active hepatitis or cirrhosis.\n* Serum creatinine \\> 2 mg/dL or estimated creatinine clearance \\< 50 mL/min\n* Evidence of uncontrolled bacterial, viral or fungal infection prior to the conditioning regimen\n* Serious diseases that prevent patients from receiving chemotherapy treatments.\n* Concomitant neoplasms.\n* Pregnancy or breast-feeding.\n* Any other medical, surgical or psychiatric condition that is considered by the attending and/or medical team as a contraindication for intensive treatment'}, 'identificationModule': {'nctId': 'NCT02386332', 'briefTitle': 'A Randomized Multicenter Study to Compare Two Types of Transplant in Adult Patients With Hematologic Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigacion Sanitaria La Fe'}, 'officialTitle': 'A Randomized Multicenter Study Comparing Unrelated Umbilical-cord Blood Transplant Versus Human Leukocyte Antigen (HLA)-Haploidentical Related Hematopoietic Stem Cell Transplant for Adult Patients With Hematologic Malignancies', 'orgStudyIdInfo': {'id': 'TPH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'umbilical cord blood transplant (UCBT)', 'description': 'Patients to receive umbilical cord blood transplant (UCBT) are conditioned with the myeloablative conditioning regimen (preparative therapy with thiotepa, fludarabine, intravenous busulfan and anti-thymocyte globulin.). Also receive GVHD prophylaxis with cyclosporine A and prednisone and Additional Supportive Care', 'interventionNames': ['Procedure: transplantation']}, {'label': 'HLA-haploidentical hematopoietic stem cell transplantation', 'description': 'Patients to receive HLA-haploidentical hematopoietic stem cell transplantation are conditioned with the myeloablative conditioning regimen (preparative therapy with thiotepa, fludarabine, intravenous busulfan). Also receive GVHD prophylaxis with cyclophosphamide, cyclosporine A and mycophenolate mofetil and Additional Supportive Care', 'interventionNames': ['Procedure: transplantation']}], 'interventions': [{'name': 'transplantation', 'type': 'PROCEDURE', 'armGroupLabels': ['HLA-haploidentical hematopoietic stem cell transplantation', 'umbilical cord blood transplant (UCBT)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Miguel A Sanz, MD', 'role': 'CONTACT', 'email': 'msanz@uv.es', 'phone': '+34.961.245875'}], 'overallOfficials': [{'name': 'Miguel A Sanz, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital La Fe, Valencia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigacion Sanitaria La Fe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}