Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-05 @ 1:58 AM
Study NCT ID:
NCT02845232
Status:
COMPLETED
Last Update Posted:
2016-07-27
First Post:
2016-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Economic Analysis of Blood Product Transfusions According to the Treatment of Acute Myeloid Leukaemia in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001803', 'term': 'Blood Transfusion'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-22', 'studyFirstSubmitDate': '2016-07-20', 'studyFirstSubmitQcDate': '2016-07-22', 'lastUpdatePostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimation of mean blood product transfusions costs (in euros) per patient according to overall survival', 'timeFrame': 'From starting treatment to death from any cause (up to 21 months)', 'description': 'The cost-effectiveness of blood product transfusion was determined among initial treatment subgroups: patients receiving intensive chemotherapy, patients receiving low-intensity treatments, and patients treated only by BSC.'}], 'secondaryOutcomes': [{'measure': 'Complete remission (CR) rate', 'timeFrame': 'Duration of study (Month 21)', 'description': 'Complete remission (CR) was defined by bone marrow aspiration, which was required to consist of more than 50% normal cellularity with evidence of trilineage maturation and less than 5% bone marrow blasts, no evidence of extramedullary disease, and regeneration of the peripheral neutrophil count to 1.0 × 109/L and the platelet count to 100 × 109/L. The persistence of myelodysplastic features did not exclude the diagnosis of CR.'}, {'measure': 'Number of blood product transfusions per patient', 'timeFrame': 'Duration of study (Month 21)', 'description': 'Decisions concerning transfusion indications were based on institutional policy and the clinical judgment of treating physicians. Transfusion practice was consistent during the period of study. Prophylactic transfusions were consistently given at morning platelet counts of \\< 20 ×109/L and haemoglobin level \\< 80 g/L. Protocol Blood products were leukoreduced through discarding the buffy coat and administered through a standard 140 to 170 µm blood filter but were not irradiated'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute myeloid leukemia', 'Therapy', 'Blood transfusion', 'Cost-effectiveness', 'Prognosis'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': "Blood transfusion requirement represents one of the most significant cost driver associated with acute myeloid leukemia (AML). In addition to an increase prevalence of co morbidities in older patients, AML in older patients is more often associated with adverse features than in younger adults. Physicians might therefore decide to offer palliative or supportive care rather than intensive chemotherapy. An alternative treatment could be low-intensity therapy, such as LD-AraC or hypomethylating agents, which demonstrated better results than only Best Supportive care (BSC). Blood transfusion requirement represents one of the most significant cost driver associated with AML.\n\nThe present study assesses the cost-effectiveness of intensive chemotherapy versus Best Supportive Care (BSC) versus alternative therapies (hypomethylating agents, low-dose cytosine arabinoside (LD-AraC), or other investigational drugs) in elderly patients aged 70 years or older regarding blood product transfusions from a French payer perspective. Intensive chemotherapy and BSC were the comparators in this analysis, since they continue to represent the most commonly used treatment for elderly AML according to the defined status of patients considered as 'fit' or 'unfit' for intensive chemotherapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Three groups of elderly patients aged 70 years or older, with AML. First group: 68 patients receiving a combination of intermediate-dose cytarabine and an anthracycline. One patient with acute promyelocytic leukaemia (APL) also received all-trans retinoic acid (ATRA).\n\nThe second study group comprised 70 patients who were treated on frontline by lower-intensity treatments \\[LD-AraC(39 patients), azacitidine (16 patients), decitabine (11 patients),tipifarnib (3 patients), or ATRA (1 patient)\\].\n\nThe last study group comprises 76 patients: 31 patients received supportive care, while 36 patients also received hydroxyurea and 9 patients received 6-mercaptopurine.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 70 years old\n* AML according to the World Health Organization (WHO) criteria (% of blasts ≥ 20% in bone marrow aspiration).\n* All FAB subtypes.\n* Any type of AML (de novo or secondary)\n* All participants to clinical trials gave their written informed consent\n\nExclusion Criteria:\n\n* Have an Eastern Cooperative Oncology Group (ECOG) score ≥2\n* Active uncontrolled infection'}, 'identificationModule': {'nctId': 'NCT02845232', 'briefTitle': 'Economic Analysis of Blood Product Transfusions According to the Treatment of Acute Myeloid Leukaemia in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Economic Analysis of Blood Product Transfusions According to the Treatment of Acute Myeloid Leukaemia in the Elderly', 'orgStudyIdInfo': {'id': '69HCL16_0461'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intensive chemotherapy', 'description': 'First group: 68 patients receiving a combination of intermediate-dose cytarabine and an anthracycline. One patient with acute promyelocytic leukaemia (APL) also received all-trans retinoic acid (ATRA).', 'interventionNames': ['Other: Transfusion']}, {'label': 'Lower-intensity treatments', 'description': "The second study group comprised 70 patients who were treated on frontline by lower-intensity treatments \\[LD-AraC(39 patients), azacitidine (16 patients), decitabine (11 patients),tipifarnib (3 patients), or ATRA (1 patient)\\]. Patients received LD-AraC 20 mg once or twice daily (according to physician'schoice) by subcutaneous injection for 10 consecutive days. Azacitidine was given at the dose of 75 mg/m2/day for 7 consecutive days by sc injection. Decitabine was administered by intravenous route once daily at 20 mg/m2 for 5 consecutive days. Tipifarnib was given at 600 mg administered orally twice daily for 21 consecutive days in 4-week cycles. ATRA was given at 45 mg/m2until CR achievement followed by maintenance combining 6-mercaptopurine with methotrexate.", 'interventionNames': ['Other: Transfusion']}, {'label': 'Best Supportive Care', 'description': 'The last study group comprises 76 patients: 31 patients received supportive care, while 36 patients also received hydroxyurea and 9 patients received 6-mercaptopurine.', 'interventionNames': ['Other: Transfusion']}], 'interventions': [{'name': 'Transfusion', 'type': 'OTHER', 'description': 'The number and type of blood products administered were registered from the time of diagnosis to the time of death corresponding for all patients to the time of last follow-up. Transfusion of a single unit of packed red blood cell (PRBC) or one whole blood-derived platelet concentrate (PC) or fresh frozen plasma (FFP) was considered a transfusion event and considered for statistical analysis.', 'armGroupLabels': ['Best Supportive Care', 'Intensive chemotherapy', 'Lower-intensity treatments']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69310', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'overallOfficials': [{'name': 'Xavier THOMAS, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon - Centre Hospitalier Lyon Sud'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}