Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT01627132
Status:
UNKNOWN
Last Update Posted:
2012-06-25
First Post:
2012-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia-CP Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial
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': 'D000069439', 'term': 'Dasatinib'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-22', 'studyFirstSubmitDate': '2012-02-14', 'studyFirstSubmitQcDate': '2012-06-22', 'lastUpdatePostDateStruct': {'date': '2012-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib.', 'timeFrame': 'at 12 months'}], 'secondaryOutcomes': [{'measure': 'Rate of complete molecular remission that will be sustained after dasatinib rechallenge.', 'timeFrame': 'at 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '32614159', 'type': 'DERIVED', 'citation': 'Kumagai T, Nakaseko C, Nishiwaki K, Yoshida C, Ohashi K, Takezako N, Takano H, Kouzai Y, Murase T, Matsue K, Morita S, Sakamoto J, Wakita H, Sakamaki H, Inokuchi K; Kanto CML, Shimousa Hematology Study Groups. Silent NK/T cell reactions to dasatinib during sustained deep molecular response before cessation are associated with longer treatment-free remission. Cancer Sci. 2020 Aug;111(8):2923-2934. doi: 10.1111/cas.14518. Epub 2020 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission (CMR) while on dasatinib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic Myeloid Leukemia in the Chronic Phase.\n* Patients with BCR-ABL-negative checks.\n* 15 years old over.\n* ECOG performance status (PS) score 0-2.\n* Adequate organ function (hepatic, renal and lung).\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* A case with the double cancer of the activity.\n* Women who are pregnant or breastfeeding.\n* Patients with complications or a history of severe.\n* Patients with mutation of T315I、F317L、V299L.\n* Patients with additional chromosome abnormalities.\n* The case of Pleural effusion with poor control.\n* Patients with a history of hematopoietic stem cell transplantation.'}, 'identificationModule': {'nctId': 'NCT01627132', 'briefTitle': 'Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia-CP Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial', 'organization': {'class': 'OTHER', 'fullName': 'Shimousa Hematology Study Group'}, 'officialTitle': 'Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial', 'orgStudyIdInfo': {'id': 'SHSG-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dasatinib', 'interventionNames': ['Drug: Dasatinib']}], 'interventions': [{'name': 'Dasatinib', 'type': 'DRUG', 'otherNames': ['BMS-354825'], 'description': '100mg QD', 'armGroupLabels': ['dasatinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '113-8603', 'city': 'Sendagi 1-1-5', 'state': 'Bunkyo-ku,Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Koiti Inokuchi, MD,PhD', 'role': 'CONTACT', 'email': 'inokuchi@nms.ac.jp', 'phone': '+81(0)3-3822-2131'}, {'name': 'Hisashi Wakita, MD,PhD', 'role': 'CONTACT', 'email': 'wakita@naritasekijuji.jp', 'phone': '+81(0)476-22-2311'}, {'name': 'Koiti Inokuchi, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nippon Medical School'}], 'centralContacts': [{'name': 'Koiti Inokuchi, MD,PhD', 'role': 'CONTACT', 'email': 'inokuchi@nms.ac.jp', 'phone': '+81(0)3-3822-2131'}], 'overallOfficials': [{'name': 'Koiti Inokuchi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nippon Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shimousa Hematology Study Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Epidemiological and Clinical Research Information Network', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nippon Medical School', 'investigatorFullName': 'Koiti Inokuchi,MD,PhD.', 'investigatorAffiliation': 'Shimousa Hematology Study Group'}}}}