Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT03599869
Status:
UNKNOWN
Last Update Posted:
2018-07-26
First Post:
2018-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Management of Mixed-Phenotype Acute Leukemia in the East of France
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015456', 'term': 'Leukemia, Biphenotypic, Acute'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-24', 'studyFirstSubmitDate': '2018-06-22', 'studyFirstSubmitQcDate': '2018-07-24', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Age of the patients when diagnosed with MPAL', 'timeFrame': 'At inclusion (Day 0)', 'description': 'Age in years'}, {'measure': 'Sex of the patients when diagnosed with MPAL', 'timeFrame': 'At inclusion (Day 0)', 'description': 'Male or female'}, {'measure': 'City of the hematology unit in charge of each patient for the treatment of MPAL', 'timeFrame': 'At inclusion (Day 0)', 'description': 'Nancy, Metz-Thionville, Reims, Strasbourg, Mulhouse, Dijon or Besançon'}, {'measure': 'MPAL rate in the each hematology unit', 'timeFrame': '10 years (01/01/2008-01/01/2018)', 'description': 'Rate of MPAL out of the total number of patients diagnosed with acute leukemia in each hematology unit'}, {'measure': 'Date of MPAL diagnosis for each patient', 'timeFrame': 'At inclusion (Day 0)'}, {'measure': 'Type of MPAL for each patient', 'timeFrame': 'At inclusion (Day 0)', 'description': 'De novo MPAL or secondary to myelodysplasia MPAL'}, {'measure': 'Percentage of blood blasts for each patient at diagnosis of MPAL', 'timeFrame': 'At inclusion (D0)', 'description': 'On the first blood sample analyzed'}, {'measure': 'Percentage of medullar blasts for each patient at diagnosis of MPAL', 'timeFrame': 'At inclusion (Day 0)', 'description': 'On the first bone marrow sample analyzed'}, {'measure': 'Cytologic characteristics: type of myeloid markers at diagnosis for each patient', 'timeFrame': 'At inclusion (Day 0)', 'description': 'Presence or not of myeloid markers generally sought in the diagnosis of acute leukaemias'}, {'measure': 'Cytologic characteristics: type of B lymphoid markers at diagnosis for each patient', 'timeFrame': 'At inclusion (Day 0)', 'description': 'Presence or not of B lymphoid markers generally sought in the diagnosis of acute leukaemias'}, {'measure': 'Cytologic characteristics: type of T lymphoid markers', 'timeFrame': 'At inclusion (D0)', 'description': 'Presence or not of T lymphoid markers generally sought in the diagnosis of acute leukemias'}, {'measure': 'Medullar MPO positivity percentage at diagnosis for each patient', 'timeFrame': 'At inclusion (Day 0)', 'description': 'If performed on the bone marrow sample used to confirm the diagnosis'}, {'measure': 'Genetic characteristics on the caryotype at diagnosis for each patient', 'timeFrame': 'At inclusion (Day 0)', 'description': 'Presence or not of caryotypic abnormalities generally sought in the diagnosis of acute leukemias'}, {'measure': 'Genetic characteristics on molecular biology analysis at diagnosis for each patient', 'timeFrame': 'At inclusion (D0)', 'description': 'Presence or not of molecular biology abnormalities generally sought in the diagnosis of acute leukemias'}, {'measure': 'Classification of biphenotypic acute leukemia (BAL) according to the EGIL 1998 criterias at diagnosis', 'timeFrame': 'At inclusion (Day 0)', 'description': 'BAL or not'}, {'measure': 'Classification of MPAL according to the WHO 2008 criterias at diagnosis', 'timeFrame': 'At inclusion (Day 0)', 'description': 'MPAL or not'}, {'measure': 'Type of treatments and dates of the first day of every treatment line for each patient', 'timeFrame': '10 years (01/01/2008-01/01/2018)', 'description': 'Myeloid or lymphoid chemotherapy regimen'}, {'measure': 'Medullar response for every treatments line for each patient', 'timeFrame': '10 years (01/01/2008-01/01/2018)', 'description': 'Complete cytological and molecular response or treatment failure'}, {'measure': 'Treatment including allogenic hematopoietic stem cells transplant (HSCT) (yes or no) with type of conditionning regimen for each patient', 'timeFrame': '10 years (01/01/2008-01/01/2018)', 'description': 'High-dose, reduced-intensity or nonmyeloablative conditioning regimens with or without total body irradiation'}, {'measure': 'HSCT complicated with acute and/or chronic graft-versus-host disease with severity grade and treatments for each patient', 'timeFrame': '10 years (01/01/2008-01/01/2018)', 'description': 'Diagnosis of GVHD according to Filipovich criterias (BMT 2005); Severity grade according to Seattle criterias; Type of treatments: steroids, other immunosuppressive agents, extracorporeal photopheresis'}], 'secondaryOutcomes': [{'measure': 'Date of every relapse for each patient', 'timeFrame': '10 years (01/01/2008-01/01/2018)'}, {'measure': 'Date of death if occured', 'timeFrame': '10 years (01/01/2008-01/01/2018)'}, {'measure': 'Cause of death', 'timeFrame': '10 years (01/01/2008-01/01/2018)', 'description': 'Secondary to leukemia, treatment or other cause'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mixed Phenotype Acute Leukemia']}, 'descriptionModule': {'briefSummary': 'Clinical presentation and management of Mixed-Phenotype Acute leukemia (MPAL) is heterogeneous. This descriptive observationnal study aims to review MPAL cases in the East of France based on a 10-year multicentre retrospective collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients from one of the following 7 hospitals : Nancy, Metz-Thionville, Reims, Strasbourg, Mulhouse, Dijon, Besançon', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients over 18 years of age\n* Diagnosis of biphenotypic acute leukemia or mixed-phenotype acute leukemia between 2008 and 2018'}, 'identificationModule': {'nctId': 'NCT03599869', 'acronym': 'ELABEST', 'briefTitle': 'Management of Mixed-Phenotype Acute Leukemia in the East of France', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Management of Mixed-Phenotype Acute Leukemia in the East of France', 'orgStudyIdInfo': {'id': 'PSS2017/ELABEST-BONMATI/VS'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}