Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT03869502
Status:
UNKNOWN
Last Update Posted:
2023-05-10
First Post:
2019-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
European CML Blast Crisis Register
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2019-03-07', 'studyFirstSubmitQcDate': '2019-03-08', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'through study completion in 2024', 'description': 'how many patients survive after a blast crisis event'}], 'secondaryOutcomes': [{'measure': 'Rate of hematologic response to treatment', 'timeFrame': 'through study completion in 2024', 'description': 'how many patients have a hematologic response to the local standard Treatment after a blast crisis event'}, {'measure': 'Rate of molecular response to treatment', 'timeFrame': 'through study completion in 2024', 'description': 'how many patients have a molecular response to the local standard Treatment after a blast crisis event'}, {'measure': 'Rate of blast crises in Europe in the era of TKI treatment', 'timeFrame': 'through study completion in 2024', 'description': 'how many patients have blast crisis events compared to all treated CML-patients in the trial centers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Myeloid Leukemia in Myeloid Blast Crisis']}, 'descriptionModule': {'briefSummary': 'Multicentric prospective and retrospective register collecting patient with CML blast crisis diagnosed in Germany and Europe', 'detailedDescription': 'Since the advent of treatment with tyrosine kinase inhibitors (TKI), the incidence of blast crises has significantly decreased. Nevertheless, about 5% of patients diagnosed with chronic myeloid leukemia (CML) will evolve into a blast phase at some point during the course of their disease. Furthermore, despite the advances made in CML treatment, outcome of patients with blast crises are still dismal. Due to the rarity of this condition clinical trials are challenging, and collaboration between researchers both at national and international level is needed to collect a meaningful number of data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with CML Blast crisis, either newly diagnosed or as evolution of a CML in chronic phase', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Diagnosis of BCR-ABL positive CML blast crisis according to the WHO criteria:\n\n * Blasts 20% or more of peripheral blood white cells or bone marrow cells or\n * Extramedullary blast proliferation or\n * Large foci or clusters of blasts in bone marrow biopsy\n\nExclusion Criteria:\n\n* Lack of informed consent'}, 'identificationModule': {'nctId': 'NCT03869502', 'acronym': 'BlastCrisis', 'briefTitle': 'European CML Blast Crisis Register', 'organization': {'class': 'OTHER', 'fullName': 'University of Jena'}, 'officialTitle': 'European CML Blast Crisis Register', 'orgStudyIdInfo': {'id': 'BlastCrisis'}}, 'contactsLocationsModule': {'locations': [{'zip': '62500', 'city': 'Brno', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Jiri Mayer, Prof. Dr.', 'role': 'CONTACT'}], 'facility': 'Masaryk University Hospital Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '01307', 'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christoph Röllig, PD Dr.', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '45147', 'city': 'Essen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Joachim R. Göthert, Dr.', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '07747', 'city': 'Jena', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Annamaria Brioli, PhD MD', 'role': 'CONTACT', 'email': 'blastcrisis@med.uni-jena.de', 'phone': '+49 36419324576'}], 'facility': 'University Hospital Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '04103', 'city': 'Leipzig', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Georg-Nikolaus Franke, Dr.', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Leipzig AöR', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '68169', 'city': 'Mannheim', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Susanne Saussele, Prof. Dr.', 'role': 'CONTACT'}], 'facility': 'Universitätsmedizin Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '48149', 'city': 'Münster', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Matthias Stelljes, Prof. Dr.', 'role': 'CONTACT'}], 'facility': 'Universitaetsklinikum Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '197022', 'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Elena Morozova, PhD Dr.', 'role': 'CONTACT'}], 'facility': 'I. P. Pavlov First St. Petersburg State Medical University', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '02000', 'city': 'Kiev', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Iryna Dyagil, Dr.', 'role': 'CONTACT'}], 'facility': 'National Research Center for Radiation Medicine', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}], 'centralContacts': [{'name': 'Annamaria Brioli, PhD MD', 'role': 'CONTACT', 'email': 'blastcrisis@med.uni-jena.de', 'phone': '+49 36419324576'}, {'name': 'Christian Fabisch, Dr.', 'role': 'CONTACT', 'email': 'blastcrisis@med.uni-jena.de', 'phone': '+49 36419396670'}], 'overallOfficials': [{'name': 'Annamaria Brioli, PhD MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univerity of Jena'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'A joint publication is planned. But no data of trial Centers will be shared with the other trial centers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Annamaria Brioli', 'investigatorAffiliation': 'University of Jena'}}}}