Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2026-02-25 @ 9:45 PM
Study NCT ID:
NCT01887561
Status:
UNKNOWN
Last Update Posted:
2013-06-27
First Post:
2013-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dasatinib for Patients Achieving Complete Molecular Response for Cure D-NewS Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}], 'ancestors': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'lastUpdateSubmitDate': '2013-06-24', 'studyFirstSubmitDate': '2013-04-11', 'studyFirstSubmitQcDate': '2013-06-24', 'lastUpdatePostDateStruct': {'date': '2013-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR', 'timeFrame': 'by 12 months'}], 'secondaryOutcomes': [{'measure': "'Dasatinib affects immunological responses, as measured by flow cytometry", 'timeFrame': 'at 3,6,12,24 months'}, {'measure': 'Major Molecular Response(MMR) rate measured by RQ-PCR', 'timeFrame': 'by 1 months, then every 6 months for 2 years'}, {'measure': 'Complete Cytogenetic Response (CCyR) rate', 'timeFrame': 'by 6,12 months'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'Participants were followed for at least 2 years'}, {'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': 'Participants were followed for at least 2 years'}, {'measure': 'The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR', 'timeFrame': 'by 3,6 months'}, {'measure': 'Molecular remission rate measured by PQ-PCR after dasatinib re-challenge in cases of molecular relapse', 'timeFrame': 'by 12 months after molecular relapse'}, {'measure': 'Complete Molecular Response(CMR) rate measured by RQ-PCR', 'timeFrame': 'by 1 months, then every 6 months for 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Myelogenous Leukemia, Chronic, Chronic Phase']}, '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': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase\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* female patient who there is not intention with an appropriate sterilization, or cannot use it during a study entry period\n* Patients with complications or a history of severe or uncontrolled cardiovascular failure following have a Myocardial infarction within 6 months have an Angina within 3 months have a Congestive heart failure within 3 months have a QTc interval of more than 450msec at baseline\n* A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy'}, 'identificationModule': {'nctId': 'NCT01887561', 'briefTitle': 'Dasatinib for Patients Achieving Complete Molecular Response for Cure D-NewS Trial', 'organization': {'class': 'OTHER', 'fullName': 'Kanto CML Study Group'}, 'officialTitle': 'Phaseâ…¡Clinical Trial of Dasatinib for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase and Stop Therapy After Achieving Complete Molecular Response for Cure D-NewS', 'orgStudyIdInfo': {'id': 'KCSG-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'treatment', 'interventionNames': ['Drug: dasatinib']}], 'interventions': [{'name': 'dasatinib', 'type': 'DRUG', 'armGroupLabels': ['treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '190-0014', 'city': 'Tachikawa', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Naoki Takesako', 'role': 'CONTACT', 'email': 'ntakezak@tdmc.hosp.go.jp', 'phone': '+81(0) 42-526-5511'}], 'facility': 'National Disaster Medical Center', 'geoPoint': {'lat': 35.7091, 'lon': 139.41891}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanto CML Study Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Kanto CML Study Group', 'investigatorFullName': 'Naoki Takezako, M.D., Ph.D.', 'investigatorAffiliation': 'Kanto CML Study Group'}}}}