Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2025-12-25 @ 10:17 PM
Study NCT ID:
NCT03547258
Status:
UNKNOWN
Last Update Posted:
2020-04-21
First Post:
2018-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Italian Non-Interventional Study of FLT3 Mutated AML Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-20', 'studyFirstSubmitDate': '2018-05-11', 'studyFirstSubmitQcDate': '2018-05-23', 'lastUpdatePostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of patients FLT3 negative at diagnosis who relapse FLT3 positive;', 'timeFrame': 'up to 24 months', 'description': 'description of how the FLT3 mutational status changes during the course and management of the disease'}, {'measure': 'percentage of patients FLT3 positive at diagnosis who relapse FLT3 negative', 'timeFrame': 'up to 24 months', 'description': 'description of how the FLT3 mutational status changes during the course and management of the disease'}], 'secondaryOutcomes': [{'measure': 'objective overall response rate (ORR)', 'timeFrame': 'up to 24 months', 'description': 'the objective overall response rate (ORR) defined as the proportion of patients with a partial or response (CR, CRi, CRp) response, to initial treatment and in case of salvage;'}, {'measure': 'disease-free survival (DFS)', 'timeFrame': 'up to 24 months', 'description': 'disease-free survival (DFS) after first CR and after CR2/CR3, if applicable, defined as the time since CR (or CR2 or CR3) to disease relapse or death for any cause, whichever occurs first.'}, {'measure': 'overall survival (OS)', 'timeFrame': 'up to 24 months', 'description': 'overall survival (OS) defined as the time since date of diagnosis until death for any cause or the last available patient contact.'}, {'measure': 'Percentage of AML patients with specific types of FLT3 mutations', 'timeFrame': 'up to 24 months', 'description': 'Percentage of AML patients with specific types of FLT3 mutations, at initial diagnosis and at disease relapse'}, {'measure': 'distribution of specific FLT3 mutations in AML patients', 'timeFrame': 'up to 24 months', 'description': 'distribution of specific FLT3 mutations in AML patients according to: age, WBC, LDH, cytogenetics, NPM1, CEBPA alterations, IDH1/2, tp53, DNMT3A, secondary vs de novo AML;'}, {'measure': 'frequency of the different methods used to evaluate (Minimal residual disease) MRD', 'timeFrame': 'up to 24 months', 'description': 'the frequency of the different methods used to evaluate MRD such as, wt1 ratio or the fusion transcript level by Reverse transcription polymerase chain reaction (RT-PCR); percentage of patients performing FLT3 ITD analysis by Next Generation Sequencing (NGS);'}, {'measure': 'FLT3-ITD allelic ratio', 'timeFrame': 'up to 24 months', 'description': 'FLT3-ITD allelic ratio defined as the ratio of the area under the curve of mutant and wild type alleles (mutant/totalFLT3) obtained after Fragment analysis for FLT3-ITD;'}, {'measure': 'transplantation percentage', 'timeFrame': 'up to 24 months', 'description': 'percentage of FLT3 mutated AML patients undergoing transplantation'}, {'measure': 'evaluation of modifications in terms of quality of life (QoL) of patients with FLT3 mutated AML', 'timeFrame': 'up to 24 months', 'description': 'scores for each patient and each scale as well as a summary QoL score will be computed according to the EORTC QLQ-C3 (quality of life questionnaire) manual'}, {'measure': 'retrospective collection of surrogate measures of QoL', 'timeFrame': 'up to 24 months', 'description': 'the surrogate measures of QoL , as the number and days of hospitalizations per patient, number of clinical visits per patient, number of access in Day Hospital and Emergency Care Units per patient, and the use of antalgic drugs and neuro-active drugs, will be expressed in terms of mean values per patient or through proportions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AML', 'Italian observational study', 'FLT3-ITD Mutation', 'FLT3-TKD Mutation'], 'conditions': ['AML', 'FLT3-ITD Mutation', 'FLT3-TKD Mutation']}, 'descriptionModule': {'briefSummary': 'This is an observational study involving a retrospective and prospective collection of clinical and molecular data regarding patients with AML with FLT3+ mutations', 'detailedDescription': 'This is an observational study involving a retrospective and prospective collection of clinical and molecular data. Patients will follow their regular diagnostic and clinical practice. Thus, no additional procedure/blood withdrawal will be performed.\n\nThe study will be conducted as follows:\n\n1. Retrospective phase: clinical and molecular data of AML patients with FLT3+ mutations detected at diagnosis or at any refractory/relapse state will be collected.\n2. Prospective phase: clinical and molecular data of each new FLT3+ AML patient identified in participating centers at diagnosis or at any refractory/relapse state will be collected prospectively. Every effort will be done to include all consecutive patients, in order to avoid selection bias.\n\nFor patients with a mutation found at the time of disease relapse, any effort will be done to collect all the clinical and molecular information since the time of diagnosis.\n\nThe Primary objective of this study is to analyze how FLT3 mutational status evolve during the management of the disease looking at the percentage of patients with no FLT3 mutations at diagnosis who relapse with a new FLT3 mutation detected, and the percentage of FLT3 positive AML patients that after having obtained a Complete Remission relapse with FLT3 negative.\n\nThe secondary objective of the study is to investigate the association between different FLT3 mutations and the clinical, molecular and biological information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patient with FLT3 mutated AML documented at diagnosis or at the time of relapse/refractory state treated in the participating center. With regards to the retrospective collection, data from the eligible and acconsenting patients will be retrieved since 2012, that is, when the evaluation of FLT3 mutation was almost routine in the centers considered in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. AML patients\n2. Male or Female\n3. Aged ≥ 18 years\n4. FLT3 mutations (ITD or TKD) positive tests performed at diagnosis or at relapse.\n5. Participant is willing and able to give informed consent for participation in the study.\n\nExclusion criteria:\n\n1\\. To be currently involved in experimental clinical protocol, or have been treated with experimental drugs are not exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT03547258', 'acronym': 'FLAM', 'briefTitle': 'Italian Non-Interventional Study of FLT3 Mutated AML Patients', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS'}, 'officialTitle': 'Italian Non-Interventional Study of FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML) Patients', 'orgStudyIdInfo': {'id': 'IRST204.01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AML patients', 'description': 'Clinical and Molecular data collection of AML Patients with FLT3 mutations (ITD or TKD)', 'interventionNames': ['Genetic: Clinical and Molecular data collection']}], 'interventions': [{'name': 'Clinical and Molecular data collection', 'type': 'GENETIC', 'description': 'Clinical and Molecular data collection at diagnosis, during treatment and at each relapse', 'armGroupLabels': ['AML patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60126', 'city': 'Ancona', 'state': 'AN', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Attilio Olivieri', 'role': 'CONTACT'}], 'facility': 'AOU Ospedali riuniti di Ancona', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '70124', 'city': 'Bari', 'state': 'BA', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Albano', 'role': 'CONTACT'}], 'facility': 'AOU Policlinico Bari - Ematologia', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '40138', 'city': 'Bologna', 'state': 'BO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cristina Papayannidis', 'role': 'CONTACT'}], 'facility': 'Università di Bologna - DIMES', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '25123', 'city': 'Brescia', 'state': 'BS', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Chiara Cattaneo', 'role': 'CONTACT'}], 'facility': 'ASST Spedali di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '09121', 'city': 'Cagliari', 'state': 'CA', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Claudio Romani', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliera G. Brotzu', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '12100', 'city': 'Cuneo', 'state': 'CN', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniele Mattei', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliera S. Croce e Carle', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'zip': '88100', 'city': 'Catanzaro', 'state': 'CZ', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano Molica', 'role': 'CONTACT'}], 'facility': 'Ematologia - Azienda Ospedaliera "Pugliese Ciaccio" di Catanzaro', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '47014', 'city': 'Meldola', 'state': 'FC', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Martinelli, MD', 'role': 'CONTACT', 'email': 'giovanni.martinelli@irst.emr.it', 'phone': '0390543739100'}, {'name': 'Maria Benedetta Giannini, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'zip': '44124', 'city': 'Cona', 'state': 'Ferrara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gian Matteo Rigolin, Prof', 'role': 'CONTACT'}], 'facility': "AOU Universitaria Arcispedale Sant'Anna", 'geoPoint': {'lat': 44.80583, 'lon': 11.7069}}, {'zip': '71013', 'city': 'San Giovanni Rotondo', 'state': 'FG', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Cascavilla, DR', 'role': 'CONTACT'}], 'facility': 'IRCCS Casa sollievo della sofferenza', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'zip': '50134', 'city': 'Florence', 'state': 'FI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alberto Bosi', 'role': 'CONTACT'}], 'facility': 'AOU Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '73100', 'city': 'Lecce', 'state': 'LE', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Di Renzo, DR', 'role': 'CONTACT'}], 'facility': 'Ospedale Vito Fazzi di Lecce', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'zip': '98125', 'city': 'Messina', 'state': 'ME', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Caterina Musolino', 'role': 'CONTACT'}], 'facility': 'AOU Policlinico Gaetano Martino', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'zip': '20122', 'city': 'Milan', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Stefano Fracchiolla, MD', 'role': 'CONTACT'}], 'facility': 'Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20132', 'city': 'Milan', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabio Ciceri', 'role': 'CONTACT'}], 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20141', 'city': 'Milan', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elisabetta Todisco', 'role': 'CONTACT'}], 'facility': 'Istituto Europeo di Oncologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '90146', 'city': 'Palermo', 'state': 'PA', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Fabbiano', 'role': 'CONTACT'}], 'facility': 'Ospedali Riuniti Villa Sofia-Cervello', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '29121', 'city': 'Piacenza', 'state': 'PC', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniele Vallisa', 'role': 'CONTACT'}], 'facility': 'Ospedale "Guglielmo da Saliceto"', 'geoPoint': {'lat': 45.05242, 'lon': 9.69342}}, {'zip': '85028', 'city': 'Rionero in Vulture', 'state': 'Potenza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pellegrino Mustu', 'role': 'CONTACT'}], 'facility': 'Irccs Crob', 'geoPoint': {'lat': 40.92328, 'lon': 15.6711}}, {'zip': '43125', 'city': 'Parma', 'state': 'PR', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Roti', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliero-Universitaria di Parma - Ematologia e CTMO', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '48121', 'city': 'Ravenna', 'state': 'RA', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Lanza, MD', 'role': 'CONTACT'}], 'facility': 'UO Ematologia, Ospedale S.Maria delle Croci', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '89123', 'city': 'Reggio Calabria', 'state': 'RC', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Esther Oliva', 'role': 'CONTACT'}], 'facility': 'Grande Ospedale Metropolitano', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'zip': '47923', 'city': 'Rimini', 'state': 'RN', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Maria Mianulli, MD', 'role': 'CONTACT'}], 'facility': 'Ospedale infermi di Rimini', 'geoPoint': {'lat': 44.05755, 'lon': 12.56528}}, {'zip': '84131', 'city': 'Salerno', 'state': 'SA', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carmine Selleri', 'role': 'CONTACT'}], 'facility': 'AOU San Giovannidi Dio e Ruggi - ematologia', 'geoPoint': {'lat': 40.67545, 'lon': 14.79328}}, {'zip': '53100', 'city': 'Siena', 'state': 'SI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Monica Bocchia', 'role': 'CONTACT'}], 'facility': 'AOC di Ematologia - AOU Senese', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'zip': '10043', 'city': 'Orbassano', 'state': 'TO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniela Cilloni', 'role': 'CONTACT'}], 'facility': 'Università di Torino - Ospedale San Luigi Gonzaga', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'zip': '10126', 'city': 'Torino', 'state': 'TO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ernesta Audisio', 'role': 'CONTACT'}], 'facility': 'AOU Città della Salute e della Scienza di Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '10128', 'city': 'Torino', 'state': 'TO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Cignetti', 'role': 'CONTACT'}], 'facility': 'A.O. Ordine Mauriziano Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '33100', 'city': 'Udine', 'state': 'UD', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Candoni', 'role': 'CONTACT'}], 'facility': 'Divisione di Ematologia - Università di Udine', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'zip': '80131', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabrizio Pane', 'role': 'CONTACT'}], 'facility': 'AO Universitaria Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '28100', 'city': 'Novara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Monia Lunghi, MD, PhD', 'role': 'CONTACT'}], 'facility': 'AOU Maggiore della carità', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'zip': '06129', 'city': 'Perugia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Paola Martelli, Prof.ssa', 'role': 'CONTACT'}], 'facility': 'AOU Santa Maria della Misericordia - Ematologia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '00168', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Simona Sica, Prof', 'role': 'CONTACT'}], 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Oriana Nanni', 'role': 'CONTACT', 'email': 'oriana.nanni@irst.emr.it', 'phone': '+390543739266'}], 'overallOfficials': [{'name': 'Giovanni Martinelli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}