Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-26 @ 11:53 AM
Study NCT ID:
NCT00005866
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2000-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S9920 Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D000754', 'term': 'Anemia, Refractory, with Excess of Blasts'}, {'id': 'D015477', 'term': 'Leukemia, Myelomonocytic, Chronic'}], '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': 'D000753', 'term': 'Anemia, Refractory'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002066', 'term': 'Busulfan'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D002072', 'term': 'Butylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008698', 'term': 'Mesylates'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-05', 'studyFirstSubmitDate': '2000-06-02', 'studyFirstSubmitQcDate': '2004-03-15', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free survival', 'timeFrame': 'every 6 months after stem cell infusion until death or 5 years'}]}, 'conditionsModule': {'keywords': ['untreated adult acute myeloid leukemia', 'refractory anemia with excess blasts', 'refractory anemia with excess blasts in transformation', 'chronic myelomonocytic leukemia', 'secondary acute myeloid leukemia', 'de novo myelodysplastic syndromes', 'secondary myelodysplastic syndromes', 'childhood myelodysplastic syndromes'], 'conditions': ['Leukemia', 'Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. It is not yet known if total-body irradiation plus peripheral stem cell transplantation is more effective with busulfan or with cyclophosphamide for myelodysplastic syndrome or acute myeloid leukemia.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of busulfan with that of cyclophosphamide in patients undergoing total-body irradiation plus peripheral stem cell transplantation for advanced myelodysplastic syndrome or related acute myeloid leukemia.', 'detailedDescription': 'OBJECTIVES: I. Compare event free survival after total body irradiation (TBI) plus busulfan versus TBI plus cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation in patients with advanced myelodysplastic syndrome (MDS) or MDS related acute myeloid leukemia. II. Determine the distribution of pharmacokinetic parameters for busulfan in those patients randomized to the busulfan treatment arm. III. Investigate the prognostic significance for event free survival of prior history of red cell transfusions, cytogenetic pattern, and of functional drug resistance at diagnosis in these patients. IV. Estimate the frequencies of cytogenetic and genetic changes during disease progression in these patients.\n\nOUTLINE: This a randomized, multicenter study. Patients are stratified according to age (40 and under vs 41-55) and diagnosis and International Prognostic Scoring System (IPSS) risk group (myelodysplastic syndrome (MDS)/IPSS - intermediate 1 vs MDS/IPSS - intermediate 2 vs MDS/IPSS high risk vs MDS related acute myeloid leukemia). Patients are randomized to one of two treatment arms. Arm I: Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 for a total of 16 doses. Arm II: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients receive total body irradiation (TBI) twice a day on days -3 to -1; peripheral blood stem cell transplantation from genotypically HLA identical sibling on day 0; cyclosporine IV every 12 hours on days -1 to 60, and then tapering in the absence of graft versus host disease; and methotrexate IV on days 1, 3, 6, and 11. Patients are followed every 6 months for 5 years.\n\nPROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this study over 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Cytologically confirmed myelodysplastic syndrome (MDS) Increased blasts (i.e., greater than 1 to 30% peripheral blood blasts and/or 5 to 30% bone marrow blasts) AND International Prognostic Score intermediate 1, intermediate 2, or high risk Refractory anemia with excess blasts OR Refractory anemia with excess blasts in transformation (no presence of auer rods as sole criteria) OR Chronic myelomonocytic leukemia Greater than 1% blasts in the peripheral blood and/or at least 5% blasts in the bone marrow OR MDS related acute myeloid leukemia Arising after documented MDS of at least 60 days Absolute peripheral blast count no greater than 5,000/mm3 Must have genotypically HLA identical sibling donor Must also be enrolled on SWOG-S9910 and SWOG-9007\n\nPATIENT CHARACTERISTICS: Age: 16 to 55 Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Other: No prior malignancy within past 5 years except: Adequately treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix Adequately treated stage I or II cancer in complete remission HIV negative Not pregnant or nursing Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: No autologous peripheral stem cell transplantation prior to diagnosis of myelodysplastic syndrome (MDS) or MDS related acute myeloid leukemia Chemotherapy: No prior chemotherapy for MDS or MDS related acute myeloid leukemia except oral chemotherapy to control leukocytosis or thrombocytosis (e.g., hydroxyurea or etoposide) Endocrine therapy: Not specified Radiotherapy: No radiotherapy prior to diagnosis of MDS or MDS related acute myeloid leukemia Surgery: Not specified'}, 'identificationModule': {'nctId': 'NCT00005866', 'briefTitle': 'S9920 Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'A Phase III Randomized Study Comparing Busulfan-Total Body Irradiation Versus Cyclophosphamide-Total Body Irradiation Preparative Regimen in Patients With Advanced Myelodysplastic Syndrome (MDS) or MDS-Related Acute Myeloid Leukemia (AML) Undergoing HLA-Identical Sibling Peripheral Blood Stem Cell Transplantation, (A BMT Study)', 'orgStudyIdInfo': {'id': 'S9920'}, 'secondaryIdInfos': [{'id': 'S9920', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment', 'interventionNames': ['Drug: busulfan', 'Drug: cyclophosphamide', 'Drug: cyclosporine', 'Drug: methotrexate', 'Procedure: allogeneic bone marrow transplantation', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'busulfan', 'type': 'DRUG', 'description': 'arm 1: 0.44 mg/kg every 6 hours, IV over 2 hours, day -7 to -4', 'armGroupLabels': ['treatment']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'description': 'arm 2: 60 mg/kg every 24 hrs for 2 doses, IV over 2 hrs, days -5 and -4', 'armGroupLabels': ['treatment']}, {'name': 'cyclosporine', 'type': 'DRUG', 'description': 'both arms per published schedule', 'armGroupLabels': ['treatment']}, {'name': 'methotrexate', 'type': 'DRUG', 'description': 'GVHD: 15 mg/m2 day 1, 10 mg/m2 day 3, 6 and 11 by IV', 'armGroupLabels': ['treatment']}, {'name': 'allogeneic bone marrow transplantation', 'type': 'PROCEDURE', 'description': 'day 0', 'armGroupLabels': ['treatment']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'description': 'both arms: 1200 cGy total dose (6 x 200 fractions)', 'armGroupLabels': ['treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85062-2989', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Good Samaritan Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Comprehensive Cancer Center', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'Cancer Center and Beckman Research Institute, City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90033-0804', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center and Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92613-5600', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'St. Joseph Hospital - Orange', 'geoPoint': 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'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '66160-7357', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '67214-3882', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'CCOP - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40536-0084', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Albert B. 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Dayton', 'geoPoint': {'lat': 39.6895, 'lon': -84.16883}}, {'zip': '73190', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97201-3098', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Cancer Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Legacy Cancer Services', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'CCOP - Columbia River Program', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence St. Vincent Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '78234', 'city': 'Fort Sam Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Brooke Army Medical Center', 'geoPoint': {'lat': 29.45303, 'lon': -98.4417}}, {'zip': '78236-5300', 'city': 'Lackland Air Force Base', 'state': 'Texas', 'country': 'United States', 'facility': 'Wilford Hall - 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Virginia Mason Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cancer Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98109-1024', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195-6043', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98401-2197', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Franciscan Health System', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '98405-0986', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'CCOP - Northwest', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jeanne E. Anderson, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Katmai Oncology Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}