Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT01417767
Status:
UNKNOWN
Last Update Posted:
2016-09-09
First Post:
2011-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS
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': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D000077209', 'term': 'Decitabine'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'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', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-08', 'studyFirstSubmitDate': '2011-08-15', 'studyFirstSubmitQcDate': '2011-08-15', 'lastUpdatePostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete remission rate', 'timeFrame': 'four weeks after one course of CHG or two courses of Decitabine'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'two years'}, {'measure': 'overall remission rate', 'timeFrame': 'four weeks after one course of CHG or two courses of Decitabine'}, {'measure': 'disease free survival', 'timeFrame': 'two years'}, {'measure': 'hematology toxicities', 'timeFrame': 'within the first 4 weeks after CHG or Decitabine regimen'}, {'measure': 'non-hematologic toxicities', 'timeFrame': 'within the first 4 weeks after CHG or Decitabine'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['myelodysplastic syndromes', 'Decitabine', 'homoharringtonine', 'cytarabine', 'G-CSF'], 'conditions': ['Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of CHG regimen (low-dose cytarabine, homoharringtonine with G-CSF priming) to decitabine in the treatment of higher-risk myelodysplastic syndromes(MDS).', 'detailedDescription': "Patients with higher-risk myelodysplastic syndrome (MDS) have a survival rate of 0.4 to 1.2 years as well as a high risk of their disease progressing to acute myeloid leukemia (AML). The only treatment with a curative potential is allogeneic stem cell transplantation. However, in the majority of patients, this treatment is not applicable, mainly due to the age of the recipients and comorbid conditions. Low-dose chemotherapy CHG regimen (low-dose cytarabine, homoharringtonine with G-CSF priming)has been used to treat higher-risk MDS in China and achieve high response rate. Hypomethylating agents 5-aza-2'-deoxycytidine (decitabine) is nucleoside analogs that covalently bind to the DNA methyltransferases, irreversibly inhibiting their function, leading to the progressive loss of methylation and reversal of gene silencing. The purpose of this study is to compare the efficacy and safety of CHG regimen to Decitabine in higher-risk MDS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age rang from 16 to 80 years;\n* diagnosis of higher-risk MDS (with≥ 5% blast in bone marrow);\n* a performance status of 0-3 according to the Eastern Cooperative Oncology Group (ECOG);\n* no evidence of severe concurrent cardiac, pulmonary, neurologic, or metabolic diseases;\n* adequate hepatic (serum bilirubin level \\<2×upper normal limit) and renal (serum creatinine \\<2×upper normal limit) function tests.\n\nExclusion Criteria:\n\n* Female with pregnancy;\n* a performance of 4-5 according to ECOG score;\n* HIV positive;\n* uncontrolled severe fungal infection or tuberculosis;\n* with other progressive malignant diseases.'}, 'identificationModule': {'nctId': 'NCT01417767', 'briefTitle': 'Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 6th People's Hospital"}, 'officialTitle': 'Phase 2/3 Study of Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS', 'orgStudyIdInfo': {'id': 'CHG-DAC 001'}, 'secondaryIdInfos': [{'id': 'SHDC12010202', 'type': 'OTHER_GRANT', 'domain': 'Shanghai Shenkang Center for hospital development'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHG regimen', 'description': 'one course of CHG regimen (low-dose cytarabine, homoharringtonine and G-CSF priming)', 'interventionNames': ['Drug: CHG regimen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Decitabine', 'description': 'one course of Decitabine (5-aza-deoxycytidine,Dacogen)', 'interventionNames': ['Drug: 5-aza-deoxycytidine']}], 'interventions': [{'name': 'CHG regimen', 'type': 'DRUG', 'otherNames': ['Low dose chemotherapy'], 'description': 'cytarabine (25mg/d, days1-14) and homoharringtonine (1mg/d, days1-14) by intravenous continuous infusion, G-CSF (300 μg/d) by subcutaneous injection from day 0 until neutrophil count recovery to 2.0× 109/L.', 'armGroupLabels': ['CHG regimen']}, {'name': '5-aza-deoxycytidine', 'type': 'DRUG', 'otherNames': ['Dacogen'], 'description': 'Decitabine (5-aza-deoxycytidine)for injection, 20mg/m2/day, IV (in the vein) on days 1-5 of each 28 day cycle, Number of Cycles: 2.', 'armGroupLabels': ['Decitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200233', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Xiao Li', 'role': 'CONTACT', 'email': 'lixiao3326@yahoo.com.cn'}, {'name': 'Xiao Li', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Shanghai 6th People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiao Li, Doctor', 'role': 'CONTACT', 'email': 'lixiao3326@yahoo.com.cn', 'phone': '008621-64369181-58745'}, {'name': 'Lingyun Wu, Doctor', 'role': 'CONTACT', 'email': 'wu_lingyun@126.com', 'phone': '008621-64369181-58336'}], 'overallOfficials': [{'name': 'Xiao Li, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': "Shanghai 6th People's Hospital"}, {'name': 'Lingyun Wu, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': "Shanghai 6th People's Hospital"}, {'name': 'Chunkang Chang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai 6th People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiao Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Xiao Li', 'investigatorAffiliation': "Shanghai 6th People's Hospital"}}}}