Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2026-02-25 @ 4:49 PM
Study NCT ID:
NCT02013102
Status:
UNKNOWN
Last Update Posted:
2013-12-17
First Post:
2013-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ⅳ Study of Decitabine in Myelodysplastic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-11', 'studyFirstSubmitDate': '2013-12-09', 'studyFirstSubmitQcDate': '2013-12-11', 'lastUpdatePostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.', 'timeFrame': '2-4 months', 'description': 'The primary efficacy evaluation: ORR The secondary efficacy evaluation: CR，mCR，PR，HI, PFS in one year, Cytogenetic response, transfusion requirements, et al.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Myelodysplastic Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate of the safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.', 'detailedDescription': 'Total subjects: 240, doseⅠgroup of 120 patients, doseⅡgroup of 120 patients. Subjects are stratified randomize. If necessary, participants accepted best supportive therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age≥18;\n* The diagnosis of MDS patients comply WHO2008 standards;\n* IPSS score≥0.5;\n* WHO classification for patients RCUD, RARS and transfusion-dependent RCMD;\n* ECOG PS score: 0-2;\n* Expected survival≥3 months;\n* Serum bilirubin≤1.5\\*ULN, serum ALT and AST≤2.5\\*ULN, serum Cr≤1.5\\*ULN;\n* Subjects signed informed consent form in line with GCP requirements.\n\nExclusion Criteria:\n\n* Can not marrow biopsy;\n* Previously diagnosed AML;\n* Received azacitidine or decitabine treatment any time before;\n* Being diagnosed with other malignancies in the prior 12 months;\n* Pregnant or lactating women;\n* Failure to control systemic fungal, bacterial or viral infection;\n* Known or suspected allergy to decitabine;\n* Known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection;\n* Have a history of neurological or psychiatric disorders, including epilepsy or dementia;\n* CTCAE 3 or 4 degree peripheral neuropathy;\n* According to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the patients completed the study in patients;\n* Using other experimental drugs or participating in other clinical trials in the prior one months."}, 'identificationModule': {'nctId': 'NCT02013102', 'acronym': 'DREAM', 'briefTitle': 'A Phase Ⅳ Study of Decitabine in Myelodysplastic Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cttq'}, 'officialTitle': 'A Randomized, Controlled, Multi-center Collaborative Phase Ⅳ Study to Evaluate the Safety and Efficacy of Decitabine in Myelodysplastic Syndrome', 'orgStudyIdInfo': {'id': 'DREAM-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm Ⅰ', 'description': 'Decitabine Injection 20mg/m2/d\\*5d, IV\\> 1h, one cycles per 4 weeks.', 'interventionNames': ['Drug: Decitabine Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Arm Ⅱ', 'description': 'Decitabine Injection 12mg/m2/d\\*8d, IV\\> 1h, one cycles per 4 weeks.', 'interventionNames': ['Drug: Decitabine Injection']}], 'interventions': [{'name': 'Decitabine Injection', 'type': 'DRUG', 'otherNames': ['qingweike'], 'description': 'Decitabine Injection 20mg/m2/d\\*5d, IV\\> 1h, one cycles per 4 weeks; Decitabine Injection 12mg/m2/d\\*8d, IV\\> 1h, one cycles per 4 weeks.', 'armGroupLabels': ['Arm Ⅰ', 'Arm Ⅱ']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'LIU HUI, MD', 'role': 'CONTACT'}, {'name': 'Shao Zonghong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Liu Hui, MD', 'role': 'CONTACT', 'phone': '0086-022-60362636'}], 'overallOfficials': [{'name': 'Shao Zonghong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Medical University General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cttq', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}