Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-02-25 @ 7:28 PM
Study NCT ID:
NCT01400633
Status:
COMPLETED
Last Update Posted:
2015-05-25
First Post:
2011-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study for Dacogen Long-Term Treatment in Patients With 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-22', 'studyFirstSubmitDate': '2011-07-14', 'studyFirstSubmitQcDate': '2011-07-21', 'lastUpdatePostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall response rate', 'timeFrame': 'every 28 days up to approximately 5 years'}], 'secondaryOutcomes': [{'measure': 'The change of transfusion requirements', 'timeFrame': 'every 4 weeks up to approximately 5 years'}, {'measure': 'Overall survival', 'timeFrame': 'every 3 months up to approximately 5 years'}, {'measure': 'Adverse events', 'timeFrame': 'every 4 weeks up to approximately 5 years'}]}, 'conditionsModule': {'keywords': ['Myelodysplastic Syndrome', 'Dacogen', 'decitabine', 'epigenetic therapy', 'hypomethylating agent'], 'conditions': ['Myelodysplastic Syndromes']}, 'referencesModule': {'references': [{'pmid': '31375393', 'type': 'DERIVED', 'citation': 'Jung KS, Kim YJ, Kim YK, Park SK, Kim HG, Kim SJ, Park J, Choi CW, Do YR, Kim I, Park S, Mun YC, Jeong SH, Kim MK, Yi HG, Chang MH, Kim SY, Lee JH, Jang JH. Clinical Outcomes of Decitabine Treatment for Patients With Lower-Risk Myelodysplastic Syndrome on the Basis of the International Prognostic Scoring System. Clin Lymphoma Myeloma Leuk. 2019 Oct;19(10):656-664. doi: 10.1016/j.clml.2019.06.003. Epub 2019 Jun 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the overall response rate (ORR) and safety when treating patients with myelodysplastic syndrome with decitabine. Decitabine is to be administered as long as there is evidence of clinical benefit.', 'detailedDescription': 'This study is a prospective (the study follows a group of individuals over time), open label (all people involved know the identity of the intervention), multicenter, single arm (one group of patients receiving the same treatment), observational study to observe the response rate and safety of decitabine when treating patients with myelodysplastic syndrome with decitabine. Decitabine is to be administered as long as there is evidence of clinical benefit. It will be assessed if the treatment duration could be prolonged by appropriate toxicity management such as an active antibiotic prophylaxis or dose and schedule modification, and whether this leads to potentially increased clinical benefits such as higher response rate, longer time to Acute Myeloid Leukemia, and prolonged overall survival. For safety evaluation, adverse events and peripheral blood findings will be collected. The patient will receive decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Secondary or tertiary hospitals in South Korea', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients diagnosed with (primary or secondary) Myelodysplastic Syndrome including Chronic Myelomonocytic Leukemia (CMML)\n* Patients with an International Prognostic Scoring System \\>= Int-1\n* Patients who were never treated with hypomethylating agent (azacitidine and decitabine)\n* Female patients who are postmenopausal or received contraceptive operation or refrain from sexual relations. Women of childbearing potential should conduct an effective method of birth control (oral contraceptives, injections, intrauterine device, double barrier method, contraceptive patch and male partner's sterilization), in case of male patients who will not have a baby within 2 months after the completion of decitabine therapy\n* Patients who signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.\n\nExclusion Criteria:\n\n* Patients diagnosed with Acute Myelogenous Leukemia (AML, bone marrow stem cell counts exceeding 20%) or other progressive malignant diseases\n* Patients with active infection of virus or bacteria\n* Patients who used to be treated with azacitidine or decitabine\n* Patients who are hypersensitive to excipients of decitabine\n* Patients who are pregnant or breast-feeding."}, 'identificationModule': {'nctId': 'NCT01400633', 'briefTitle': 'An Observational Study for Dacogen Long-Term Treatment in Patients With Myelodysplastic Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Korea, Ltd., Korea'}, 'officialTitle': 'A Prospective Multicenter Observational Study for Dacogen Long-Term Treatment in Patients With Myelodysplastic Syndrome', 'orgStudyIdInfo': {'id': 'CR017842'}, 'secondaryIdInfos': [{'id': 'DACOGENMDS4013', 'type': 'OTHER', 'domain': 'Janssen Korea, Ltd., Korea'}, {'id': 'Long-term treatment of Dacogen', 'type': 'OTHER', 'domain': 'Janssen Korea, Ltd., Korea'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '001', 'description': 'decitabine injection decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks', 'interventionNames': ['Drug: decitabine injection']}], 'interventions': [{'name': 'decitabine injection', 'type': 'DRUG', 'description': 'decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks', 'armGroupLabels': ['001']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ansan', 'country': 'South Korea', 'geoPoint': {'lat': 36.8741, 'lon': 126.2116}}, {'city': 'Anyang', 'country': 'South Korea', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'city': 'Busan', 'country': 'South Korea', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Cheonan', 'country': 'South Korea', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Chungcheongbuk-Do', 'country': 'South Korea'}, {'city': 'Daegu', 'country': 'South Korea', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'country': 'South Korea', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Hwasun Gun', 'country': 'South Korea'}, {'city': 'Incheon', 'country': 'South Korea', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Jinju', 'country': 'South Korea', 'geoPoint': {'lat': 35.19278, 'lon': 128.08472}}, {'city': 'Jungnam', 'country': 'South Korea', 'geoPoint': {'lat': 36.27333, 'lon': 128.02522}}, {'city': 'Kwanju', 'country': 'South Korea'}, {'city': 'Pusan', 'country': 'South Korea', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'country': 'South Korea', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Janssen Korea, Ltd. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Korea, Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Korea, Ltd., Korea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}