Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-30 @ 8:23 PM
Study NCT ID:
NCT00042003
Status:
COMPLETED
Last Update Posted:
2024-08-02
First Post:
2002-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Blast Phase Who Are Refractory to Imatinib Mesylate (Gleevec)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D001752', 'term': 'Blast Crisis'}], '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'}, {'id': 'D002471', 'term': 'Cell Transformation, Neoplastic'}, {'id': 'D063646', 'term': 'Carcinogenesis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077209', 'term': 'Decitabine'}], 'ancestors': [{'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2002-07-19', 'studyFirstSubmitQcDate': '2002-07-22', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2002-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic myelogenous leukemia', 'CML', 'CML-BP', 'Blast phase', 'Decitabine', "5-aza-2'deoxycytidine", 'Methylation', 'STI 571', 'Imatinib mesylate', 'Gleevec', 'BCR/ABL'], 'conditions': ['Chronic Myelogenous Leukemia']}, 'descriptionModule': {'briefSummary': 'To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia blastic phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion:\n\n* Histologically confirmed diagnosis of CML blast phase\n* Ph chromosome-positive\n* Previous treatment with imatinib mesylate resulting in: i) Hematologic Resistance / Hematologic Refractory: Based on a physician's (documented) decision to discontinue imatinib mesylate treatment due to failure of continued benefit or no benefit to the patient, ii) Imatinib Mesylate Intolerance: any toxicity resulting in a physician's (documented) decision to discontinue imatinib mesylate treatment.\n* Patients must have recovered from the side effects of previous CML therapy for blast phase with the exception of hydroxyurea\n* Age \\>/= 2 years\n* Bilirubin \\</= 3 x the upper limit of normal (ULN), SGOT and SGPT \\</= 3 x ULN, except \\</= 5 x ULN in leukemic involvement of the liver, serum creatinine \\</= 2 x ULN\n* WHO performance status 0-3\n* A negative serum hCG pregnancy test in patients of childbearing potential\n* Able to give signed informed consent directly or through a parent or guardian for minors\n\nExclusion:\n\n* Leukemic involvement of the central nervous system\n* Active malignancy other than CML or non-melanoma cancer of the skin\n* Previous treatment for CML with another investigational agent within 28 days of study entry\n* At study entry, patients who were treated with: imatinib mesylate within the past 48 hours, interferon-alpha within the past 48 hours; homoharringtonine within the past 14 days; low-dose cytosine arabinoside within 7 days, moderate dose within 14 days, or high dose within 28 days; etoposide, anthracyclines, or mitoxantrone within 21 days; busulfan within the past six weeks\n* Patients who had received hematopoietic stem cell transplantation within 6 weeks of Day 1 decitabine therapy\n* Patients with Grade 3/4 cardiac disease or any other serious concurrent medical condition.\n* Patients who are pregnant or nursing. All patients of childbearing potential must practice effective methods of contraception while on study.\n* Patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements\n* Patients with systemic, uncontrolled infections"}, 'identificationModule': {'nctId': 'NCT00042003', 'briefTitle': 'Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Blast Phase Who Are Refractory to Imatinib Mesylate (Gleevec)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astex Pharmaceuticals, Inc.'}, 'officialTitle': "A Phase II, Multicenter Study of Decitabine (5-aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Blast Phase Refractory to Imatinib Mesylate (STI 571)", 'orgStudyIdInfo': {'id': 'DAC-012'}, 'secondaryIdInfos': [{'id': 'DACO-012'}]}, 'armsInterventionsModule': {'interventions': [{'name': "decitabine (5-aza-2'deoxycytidine)", 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Metro-Minnesota CCOP', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'New York Medical College', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Liberty Hematology/Oncology', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astex Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eisai Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}