Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
Study NCT ID:
NCT03558412
Status:
UNKNOWN
Last Update Posted:
2018-09-14
First Post:
2018-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial of Decitabine in Relapsed or Refractory T-lymphoblastic Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054218', 'term': 'Precursor T-Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-12', 'studyFirstSubmitDate': '2018-06-04', 'studyFirstSubmitQcDate': '2018-06-04', 'lastUpdatePostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RR', 'timeFrame': 'up to 2 months', 'description': 'Responder Rate'}, {'measure': 'TTP', 'timeFrame': 'up to 2 months', 'description': 'Time To Progression'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': 'up to 2 months', 'description': 'Overall Survival'}, {'measure': 'MST', 'timeFrame': 'up to 2 months', 'description': 'Median Survival Time'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Decitabine', 'RR', 'TTP', 'OS', 'MST'], 'conditions': ['T-lymphoblastic Lymphoma']}, 'descriptionModule': {'briefSummary': 'To explore the safety, tolerability, and clinical effects of decitabine combined with Second-line chemotherapy regimens for patients with relapsed or refractory T-lymphoblastic lymphoma.', 'detailedDescription': 'This is a prospective, open，investigator initial clinical trial with a single arm, aimed to evaluate the safety, tolerability, and efficacy of decitabine combined with Second-line chemotherapy regimens (CODOX-M/IVAC) in relapsed or refractory T-lymphoblastic lymphoma. A total of 40 patients are planned to be enrolled into the study. Patients with diagnosis of relapsed or refractory T-lymphoblastic lymphoma will be treated with decitabine plus CODOX-M/IVAC. The primary end point is responder rate (RR) and time to progression (TTP), and the secondary end points include overall survival (OS) and the median survival time (MST).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 14\\~60 years; ECOG rate ≤ 2; expected survival \\> 3 months;\n* patients with T-lymphoblastic lymphoma diagnosed by histopathology detection;\n* patients ever received chemotherapy and/or radiotherapy;and can not be transplanted hematopoietic stem cells;\n* patients with no chemotherapy contraindications: hemoglobin ≥ 90 g/L, absolute neutrophil count ≥1.5 x 109/L, blood platelet ≥100 x 109/L, ALT and AST ≤ 2-fold upper normal limit, serum bilirubin ≤ 1.5-fold upper normal limit, serum creatinine ≤ 1.5-fold upper normal limit, serum albumin ≥ 30 g/L, normal serofibrinogen;\n* at least one measurable nidus;\n* no other severe diseases conflict with this project, cardiopulmonary function is basically normal;\n* the urine or blood pregnancy test of women in childbearing age must be negative in 7 days before follow-up visit;\n* applicable for follow-up visit;\n* no other antitumor adjoint therapy (including antitumor Chinese medicine, immunotherapy and biotherapy), but double phosphate anti-bone transfer therapy and other symptomatic treatment are acceptable;\n* understanding this study and assigning informed consent.\n\nExclusion Criteria:\n\n* rejecting providing blood preparation;\n* allergic to drug in this study and with metabolic block;\n* rejecting adopting reliable contraceptive method in pregnancy or lactation period;\n* uncontrolled internal medicine disease (including uncontrolled diabetes, severe incompetence cardiac, lung, liver and pancreas);\n* with severe infection;\n* with primary or secondary central nervous system tumor invasion;\n* with immunotherapy or radiotherapy contraindication;\n* ever suffered with malignant tumor;\n* having peripheral nervous system disorder or dysphrenia;\n* with no legal capacity, medical or ethical reasons affecting research proceeding;\n* participating other clinical trials simultaneously;\n* adopting other anti-tumor medicine excluding this research;\n* the researchers considering it inappropriate to participate in the study.'}, 'identificationModule': {'nctId': 'NCT03558412', 'briefTitle': 'A Clinical Trial of Decitabine in Relapsed or Refractory T-lymphoblastic Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Zhengzhou University'}, 'officialTitle': 'A Clinical Trial of Decitabine Combined With CODOX-M/IVAC in Relapsed or Refractory T-lymphoblastic Lymphoma', 'orgStudyIdInfo': {'id': 'hnslblzlzx20171118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'Decitabine+CODOX-M/IVAC for patients with relapsed or refractory T-lymphoblastic lymphoma who used Hyper-CVAD or BFM-90 as first-line therapy:regimen A:CODOX-M:cyclophosphamide,epirubicin,vincristine,methotrexate.Regimen B :IVAC:ifosfamide,etoposide，cytarabine.Decitabine,10mg,ivgtt,used for 5 days before A+B.', 'interventionNames': ['Combination Product: CODOX-M/IVAC', 'Drug: Decitabine']}], 'interventions': [{'name': 'CODOX-M/IVAC', 'type': 'COMBINATION_PRODUCT', 'description': 'Given ivgtt', 'armGroupLabels': ['Arm A']}, {'name': 'Decitabine', 'type': 'DRUG', 'otherNames': ["5-Aza-2'-deoxycytidine"], 'description': 'Given ivgtt', 'armGroupLabels': ['Arm A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450052', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mingzhi Zhang, Pro,Dr', 'role': 'CONTACT', 'email': 'mingzhi_zhang@126.com', 'phone': '13838565629'}, {'name': 'Mingzhi Zhang, Pro,Drc', 'role': 'CONTACT', 'email': 'mingzhi_zhang@126.com', 'phone': '13838565629'}], 'facility': 'Oncology Department of The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Mingzhi zhang, Pro,Dr', 'role': 'CONTACT', 'email': 'Mingzhi_zhang@126.com', 'phone': '13838565629'}, {'name': 'Mingzhi zhang', 'role': 'CONTACT', 'email': 'Mingzhi_zhang@126.com', 'phone': '13838565629'}], 'overallOfficials': [{'name': 'Mingzhi zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Zhengzhou University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mingzhi Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'The director of oncology department of the first affiliated hospital', 'investigatorFullName': 'Mingzhi Zhang', 'investigatorAffiliation': 'Zhengzhou University'}}}}