Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2026-02-23 @ 2:21 AM
Study NCT ID:
NCT01985061
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-15
First Post:
2013-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of 3 Different Doses of IV Busulfan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 177}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-07-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2013-10-31', 'studyFirstSubmitQcDate': '2013-11-07', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression or death', 'timeFrame': 'up to 2 years', 'description': '2-year progression free survival rates'}], 'secondaryOutcomes': [{'measure': 'Time to neutrophil>0.5G/l and platelets>50G/l', 'timeFrame': 'up to 2 months', 'description': 'hematologic recovery'}, {'measure': 'Graft versus host disease', 'timeFrame': 'up to 2 years'}, {'measure': 'relapse', 'timeFrame': 'up to 2 years'}, {'measure': 'Occurrence of grade 3-4 adverse events according the CTC-AE v4.0 scale', 'timeFrame': 'up to 6 months', 'description': 'safety'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myelodysplasic syndrome', 'Acute Myeloid leukemia'], 'conditions': ['Myelodysplastic Syndrome', 'Acute Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '26885686', 'type': 'DERIVED', 'citation': 'Wanquet A, Crocchiolo R, Furst S, Granata A, Faucher C, Devillier R, Harbi S, Lemarie C, Calmels B, Vey N, Weiller PJ, Chabannon C, Castagna L, Blaise D, El-Cheikh J. The efficacy and safety of a new reduced-toxicity conditioning with 4 days of once-daily 100 mg/m(2) intravenous busulfan associated with fludarabine and antithymocyte globulins prior to allogeneic stem cell transplantation in patients with high-risk myelodysplastic syndrome or acute leukemia. Leuk Lymphoma. 2016 Oct;57(10):2315-20. doi: 10.3109/10428194.2016.1146948. Epub 2016 Feb 17.'}], 'seeAlsoLinks': [{'url': 'http://www.institutpaolicalmettes.fr', 'label': 'official web site of the sponsor'}]}, 'descriptionModule': {'briefSummary': 'Albeit the safety of the stem cell transplantation procedure has been greatly improved, further refining the intensity of the conditioning is an important issue to explore, especially in patients with poor prognosis, the goal being to maintain the very favorable safety profile and improve the disease control. This is the goal our prospective trial; we aim to prospectively evaluate in a prospective multicenter trial the efficacy of different conditioning regimens in patients with high-risk myeloid malignancies.\n\nThe study is a phase II trial randomizing patients between a prospective active control arm (BX2) and two experimental arms (BX3 and BX4). A standard group was kept in this clinical trial in order to avoid the limitations induced by the comparison with historical controls in the context of continuously improving practice. Each experimental arm will be conducted in parallel according to a standard phase II trial design.\n\nIn addition, this trial will associate four ancillary studies to the main clinical objective: 1/ a prospective assessment of the quality of life of the patients over a period of 2 years 2/ an analysis of the cost effectiveness of the procedure, assessed over a period of 2 years 3/ an observational busulfan pharmacokinetic study 4/ a busulfan pharmacogenomic study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with poor prognosis myeloid malignancies:\n\n * Myelodysplastic syndrome,\n * Acute Myeloid Leukemia (AML) beyond Complete Response (CR1),\n * CR1 AML with poor risk cytogenetics\n2. Adult patients: aged ≥ 55 years up to 65 or \\< 55 years not eligible for myeloablative conditioning regimen based on Total Body Irradiation (TBI) or double alkylating agent combinations.\n3. Availability of a HLA identical sibling or matched unrelated donor (10/10)\n4. Affiliation to social security\n5. Written Informed Consent\n\nExclusion Criteria:\n\n1. History of previous Allo-Hematological Stem Cell Transplantation (HSCT)\n2. HIV positivity\n3. Signs of chronic active hepatitis B and/or C\n4. Evolutive psychiatric disease\n5. Concomitant neoplastic disease\n6. Pregnant or lactating woman or without contraception (for child bearing potential wom-en)\n7. Usual contra-indications for Allo-HSCT'}, 'identificationModule': {'nctId': 'NCT01985061', 'acronym': 'AAA', 'briefTitle': 'Evaluation of 3 Different Doses of IV Busulfan', 'organization': {'class': 'OTHER', 'fullName': 'Institut Paoli-Calmettes'}, 'officialTitle': 'Prospective and Multicentre Evaluation of 3 Different Doses of IV Busulfan Associated With Fludarabine and Thymoglobuline in the Conditioning of Allogeneic Stem Cell Transplantation (SCT) From a Matched Related or Unrelated Donor in Patients With Poor Prognosis Myeloid Malignancies', 'orgStudyIdInfo': {'id': 'AAA-IPC2011-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BX2', 'description': 'Fludarabine (Fludara®): 30 mg/m2 on D-6, D-5, D-4, D-3 and D-2 Busulfan IV (Busilvex®) : 3.2 mg/kg/d on D-4 and D-3 Thymoglobuline®: 2.5 mg/kg/d on D-3 and D-2', 'interventionNames': ['Drug: BX2']}, {'type': 'EXPERIMENTAL', 'label': 'BX3', 'description': 'Fludarabine (Fludara®): 30 mg/m² on D-6, D-5, D-4, D-3 and D-2 Busulfan IV (Busilvex®) : 3.2 mg/kg/d on D-5, D-4 and D-3 Thymoglobuline® : 2.5 mg/kg/d on D-3 and D-2', 'interventionNames': ['Drug: BX3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BX4-Suspended', 'description': 'Fludarabine (Fludara®): 30 mg/m²on D-6, D-5, D-4, D-3 and D-2 Busulfan IV (Busilvex®) : 3.2 mg/kg/d on D-6, D-5, D-4 and D-3 Thymoglobuline® : 2.5 mg/kg/d on D-3 and D-2', 'interventionNames': ['Drug: BX4-Suspended']}], 'interventions': [{'name': 'BX2', 'type': 'DRUG', 'otherNames': ['Busulfan Intravenous 2 days at 3.2 mg/kg/d'], 'armGroupLabels': ['BX2']}, {'name': 'BX3', 'type': 'DRUG', 'otherNames': ['Busulfan Intravenous 3 days'], 'armGroupLabels': ['BX3']}, {'name': 'BX4-Suspended', 'type': 'DRUG', 'otherNames': ['Busulfan intravenous 4 days'], 'description': 'Suspended', 'armGroupLabels': ['BX4-Suspended']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Didier BLAISE, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Paoli-Calmettes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}