Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT04360005
Status:
AVAILABLE
Last Update Posted:
2025-12-05
First Post:
2020-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Managed Access Programs for ABL001, Asciminib
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': 'C000621806', 'term': 'asciminib'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True}, 'nPtrsToThisExpAccNctId': 4}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2020-04-21', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Chronic myeloid leukemia', 'CML', 'CML-CP', 'Asciminib', 'ABL001'], 'conditions': ['Chronic Myeloid Leukemia in Chronic Phase']}, 'descriptionModule': {'briefSummary': 'The purpose of this registration form is to list all Managed Access Programs (MAPs) related to ABL001, asciminib'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. An independent request was received from a licensed physician.\n2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.\n3. The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.\n4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.\n5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).\n6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.\n7. Managed Access provision is allowed per local laws/regulations'}, 'identificationModule': {'nctId': 'NCT04360005', 'briefTitle': 'Managed Access Programs for ABL001, Asciminib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Managed Access Programs for ABL001, Asciminib', 'orgStudyIdInfo': {'id': 'CABL001A02401M'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Asciminib', 'type': 'DRUG', 'otherNames': ['ABL001'], 'description': 'Patients receive Asciminib'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'MAP requests are initiated by a licensed physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs', 'role': 'CONTACT', 'email': 'novartis.email@novartis.com', 'phone': '1-888-669-6682'}, {'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT', 'phone': '+41613241111'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}