Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-23 @ 12:19 PM
Study NCT ID:
NCT00112567
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2005-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total-Body Irradiation, Thiotepa, and Fludarabine in Treating Young Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D015465', 'term': 'Leukemia, Myeloid, Accelerated Phase'}, {'id': 'D001752', 'term': 'Blast Crisis'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002471', 'term': 'Cell Transformation, Neoplastic'}, {'id': 'D063646', 'term': 'Carcinogenesis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C042382', 'term': 'fludarabine phosphate'}, {'id': 'D013852', 'term': 'Thiotepa'}, {'id': 'D036102', 'term': 'Peripheral Blood Stem Cell Transplantation'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013721', 'term': 'Triethylenephosphoramide'}, {'id': 'D001388', 'term': 'Aziridines'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell 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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2007-07'}, 'lastUpdateSubmitDate': '2010-09-17', 'studyFirstSubmitDate': '2005-06-02', 'studyFirstSubmitQcDate': '2005-06-02', 'lastUpdatePostDateStruct': {'date': '2010-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-06-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety'}], 'secondaryOutcomes': [{'measure': 'Risk of severe graft-versus-host disease'}, {'measure': 'Kinetics of immune reconstitution'}, {'measure': 'Risk of life-threatening infections'}]}, 'conditionsModule': {'keywords': ['recurrent childhood acute lymphoblastic leukemia', 'childhood myelodysplastic syndromes', 'childhood acute lymphoblastic leukemia in remission', 'recurrent childhood acute myeloid leukemia', 'childhood acute myeloid leukemia in remission', 'secondary acute myeloid leukemia', 'accelerated phase chronic myelogenous leukemia', 'blastic phase chronic myelogenous leukemia', 'childhood chronic myelogenous leukemia', 'relapsing chronic myelogenous leukemia', 'de novo myelodysplastic syndromes', 'secondary myelodysplastic syndromes', 'previously treated myelodysplastic syndromes'], 'conditions': ['Leukemia', 'Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': "RATIONALE: Chemotherapy, such as fludarabine and thiotepa, and radiation therapy may destroy cancerous blood-forming cells (stem cells) in the blood and bone marrow. Giving healthy stem cells from a donor whose blood closely resembles the patient's blood will help the patient's bone marrow make new stem cells that become red blood cells, white blood cells, and platelets.\n\nPURPOSE: This phase I/II trial is studying the side effects of total-body irradiation, fludarabine, and thiotepa and to see how well they work in treating young patients who are undergoing a donor stem cell transplant for hematologic cancer.", 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the safety of a conditioning regimen without anti-thymocyte globulin comprising total body irradiation, thiotepa, and fludarabine followed by CD34-positive-selected haploidentical allogeneic peripheral blood stem cell transplantation in young patients with life-threatening hematologic malignancies.\n\nSecondary\n\n* Determine the risk for severe graft-vs-host disease in patients treated with this regimen.\n* Determine the kinetics of immune reconstitution in patients treated with this regimen.\n* Determine the risk for life-threatening infections in patients treated with this regimen.\n\nOUTLINE:\n\n* Conditioning regimen: Patients 7 years of age and under undergo total body irradiation twice daily on days -9 to -7. Patients over 7 years of age undergo total body irradiation once on day -7. All patients receive fludarabine IV once daily on days -6 to -2 and thiotepa IV over 2 hours twice on day -5.\n* CD34-positive (CD34+)-selected haploidentical allogeneic peripheral blood stem cell transplantation (PBSCT): Patients undergo CD34+-selected allogeneic PBSCT on days 0 and 2.\n\nPatients with acute lymphoblastic leukemia or CNS disease also receive methotrexate intrathecally twice before transplantation and 4 times after day 35 post-transplantation. Male patients with lymphoid malignancies undergo additional radiotherapy to the testes.\n\nAfter completion of study treatment, patients are followed for at least 100 days, at 1 year, and then periodically thereafter.\n\nPROJECTED ACCRUAL: A total of 20 patients (10 patients ≤ 7 years of age and 10 patients \\> 7 years of age) will be accrued for this study within 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of a life-threatening hematologic malignancy, including any of the following:\n\n * Acute leukemia advanced beyond first remission\n * Acute leukemia in first remission\\* with very high-risk prognostic features, including any of the following:\n\n * Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL)\n * ALL or acute myeloid leukemia (AML) with 11q23 chromosomal abnormality\n * Hypodiploid ALL\n * Failed to achieve first remission within 1 month after induction therapy\n * Secondary AML\n * Myelodysplastic syndromes with International Prognostic Index score \\> 1\n * Chronic myelogenous leukemia in accelerated or blast phase NOTE: \\*Must be approved by PCC\n* Haploidentical family donor available\n\n * No suitable HLA-matched related or unrelated donor available\n * No related donor mismatched for a single HLA-A, -B, -C, -DRB1, or -DQB1 antigen available\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Under 21\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* At least 6 months\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* SGPT and SGOT \\< 2 times upper limit of normal (ULN)\\*\n* Bilirubin \\< 2 times ULN\\* NOTE: \\*Unless due to malignancy\n\nRenal\n\n* Not specified\n\nCardiovascular\n\n* Ejection fraction ≥ 45%\n\nPulmonary\n\n* DLCO ≥ 60% of predicted\n\nOther\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* HIV negative\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No second bone marrow transplantation, after a first regimen containing total body irradiation\n* No concurrent growth factors until day 21 post-transplantation\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* See Biologic therapy\n\nSurgery\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00112567', 'briefTitle': 'Total-Body Irradiation, Thiotepa, and Fludarabine in Treating Young Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'A Phase I/II Study of Total Body Irradiation, Thiotepa, and Fludarabine as Conditioning for Haploidentical CD34+ Purified Peripheral Blood Stem Cell Transplants', 'orgStudyIdInfo': {'id': '1629.00'}, 'secondaryIdInfos': [{'id': 'FHCRC-1629.00'}, {'id': 'CDR0000430650', 'type': 'REGISTRY', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'fludarabine phosphate', 'type': 'DRUG'}, {'name': 'thiotepa', 'type': 'DRUG'}, {'name': 'peripheral blood stem cell transplantation', 'type': 'PROCEDURE'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98109-1023', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Ann E. Woolfrey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}