Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2026-02-03 @ 11:24 AM
Study NCT ID:
NCT02448095
Status:
TERMINATED
Last Update Posted:
2022-10-26
First Post:
2015-05-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Evaluation of CML Patients in the National Compassionate Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic 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': 'C545373', 'term': 'ponatinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'lack of interest', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2015-05-15', 'studyFirstSubmitQcDate': '2015-05-15', 'lastUpdatePostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events', 'timeFrame': 'Maximum of 60 months from treatment start', 'description': 'General adverse events and grade 3-4 adverse events according to NCI CTCAE version 4.0'}], 'secondaryOutcomes': [{'measure': 'Number of patients with hematological complete response', 'timeFrame': 'Maximum of 60 months from treatment start', 'description': 'Hematological complete response and related responses, such as major cytogenetic response, complete cytogenetic response and major molecular response.'}, {'measure': 'Number of days from treatment start till response', 'timeFrame': 'Maximum of 60 months from treatment start'}, {'measure': 'Total number of patients alive', 'timeFrame': '12 months after patient enrollment in the study', 'description': 'Overall survival'}, {'measure': 'Number of patients in event free survival', 'timeFrame': '12 months after patient enrollment in the study', 'description': 'Event free survival'}, {'measure': 'Number of patients in progression free survival', 'timeFrame': '12 months after patient enrollment in the study', 'description': 'Progression free survival'}, {'measure': 'Number of mutations', 'timeFrame': 'Maximum of 60 months from treatment start', 'description': 'Both at the beginning and at the end of treatment'}, {'measure': 'Number of units of Ponatinib administered per units of time', 'timeFrame': 'Maximum of 60 months from treatment start', 'description': 'Chemotherapy dose intensity represents unit dose of chemotherapy administered per unit time.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic myeloid leukemia', 'Philadelphia positive', 'Compassionate use'], 'conditions': ['Chronic Myeloid Leukemia', 'Philadelphia Positive']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.gimema.it', 'label': 'GIMEMA Foundation website'}]}, 'descriptionModule': {'briefSummary': 'This observational study aims at assessing the tolerability and safety profiles of Ponatinib, a drug used for Chronic Myeloid Leukemia patients who are Philadelphia positive. This drug is used during the chronic phase of the disease, according to the Italian national compassionate law 648/96.', 'detailedDescription': 'This observational study aims at assessing the tolerability and safety profiles of Ponatinib, a drug used for Chronic Myeloid Leukemia patients who are Philadelphia positive. This drug is used during the chronic phase of the disease, according to the Italian national compassionate law 648/96.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'CML Ph+ patients in the Ponatinib compassionate use program', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CML Ph+ patients in chronic phase\n* 18 years old or older\n* Patients have received either Dasatinib or Nilotinib and resulted resistant or not tolerant to the drugs or have developed the T3151 mutation\n* Patients have started Ponatinib at least 12 months before registration\n* Informed consent signed at registration\n\nExclusion Criteria:\n\n* CML Ph+ patients in accelerated or blast phase with acute lymphoblastic leukemia'}, 'identificationModule': {'nctId': 'NCT02448095', 'briefTitle': 'Retrospective Evaluation of CML Patients in the National Compassionate Program', 'organization': {'class': 'OTHER', 'fullName': "Gruppo Italiano Malattie EMatologiche dell'Adulto"}, 'officialTitle': 'Ponatinib Survey: Retrospective Evaluation of CML Patients in the National Compassionate Program According to the 648/96 Decree', 'orgStudyIdInfo': {'id': 'CML1214'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CML ph+ patients', 'description': 'Chronic myeloid leukemia patients who are philadelphia positive', 'interventionNames': ['Drug: Ponatinib']}], 'interventions': [{'name': 'Ponatinib', 'type': 'DRUG', 'description': 'Observation of tolerability and safety profiles', 'armGroupLabels': ['CML ph+ patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bari', 'country': 'Italy', 'facility': 'UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'IRCCS_AOU San Martino-IST.Clinica Ematologica', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Lecce', 'country': 'Italy', 'facility': 'ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'city': 'Milan', 'country': 'Italy', 'facility': "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Monza', 'country': 'Italy', 'facility': 'Azienda Ospedaliera "S.Gerardo"', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'city': 'Novara', 'country': 'Italy', 'facility': 'S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Orbassano', 'country': 'Italy', 'facility': 'Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2 - Orbassano', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'city': 'Pavia', 'country': 'Italy', 'facility': 'S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Reggio Calabria', 'country': 'Italy', 'facility': 'Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'U.O.C. Ematologia - Ospedale S. Eugenio', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Carmen Fava', 'role': 'STUDY_CHAIR', 'affiliation': 'Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2 - Orbassano'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gruppo Italiano Malattie EMatologiche dell'Adulto", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}