Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-29 @ 12:28 PM
Study NCT ID:
NCT01501708
Status:
UNKNOWN
Last Update Posted:
2016-05-10
First Post:
2011-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caspofungin Based Combined Anti-fungal Therapy for Proven or Probable Invasive Fungal Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077336', 'term': 'Caspofungin'}, {'id': 'D065819', 'term': 'Voriconazole'}, {'id': 'D000666', 'term': 'Amphotericin B'}], 'ancestors': [{'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D054714', 'term': 'Echinocandins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-09', 'studyFirstSubmitDate': '2011-12-26', 'studyFirstSubmitQcDate': '2011-12-26', 'lastUpdatePostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Favorable response rate', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '12 weeks, 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['caspofungin', 'IFI', 'allogeneic hematopoietic stem cell transplantation'], 'conditions': ['Leukemia', 'Transplantation, Hematopoietic Stem Cell']}, 'descriptionModule': {'briefSummary': 'In this prospective phase II observational study, we plan to assess the efficacy and tolerability of caspofungin based combined anti-fungal therapy for proven or probable IFI in a group of patients received allo-HSCT transplantation with high risk of IFI: HLA matched unrelated donor or mismatched donor conditioning with ATG containing regimen or present III-IV aGVHD or extensive GVHD undergoing high-dose steroid treatment.', 'detailedDescription': 'Patients will recieve caspofungin with either voriconazole or amphotericin B as combination therapy for fungal infection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patient undergoing allogeneic hematopoietic stem cell transplantation\n* age 18-55 years\n* with inform consent\n* no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage\n* HLA mismatched related (3\\~5/6) or unrelated donors (at least 8/10)\n* proven or probable IFI\n\nExclusion Criteria:\n\n* age less than 18 years or over 56 years\n* HLA mismatched related donor\n* liver function/renal function damage (over 2 X upper normal range)\n* with mental disease'}, 'identificationModule': {'nctId': 'NCT01501708', 'briefTitle': 'Caspofungin Based Combined Anti-fungal Therapy for Proven or Probable Invasive Fungal Infection', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Phase II Study of Caspofungin Based Combined Anti-fungal Therapy for Patients With Proven or Probable Invasive Fungal Infection After Allogeneic Stem Cell Transplantation From HLA-matched Unrelated or HLA-mismatched Related Donors', 'orgStudyIdInfo': {'id': 'RJH-2011-71'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caspofugin based combination therapy', 'description': 'Caspofugin based combination therapy:\n\nPatients will recieve caspofungin with voriconazole or amphotericin B', 'interventionNames': ['Drug: Caspofugin based combination therapy']}], 'interventions': [{'name': 'Caspofugin based combination therapy', 'type': 'DRUG', 'otherNames': ['caspofungin + voriconazole or amphotericin B'], 'description': 'Caspofungin: 70 mg on the first day of therapy, followed by 50 mg q.d.\n\n* All patients received azoles as prophylaxis (fluconazole as prophylaxis and itraconazole or voriconazole as secondary prophylaxis), combination with liposomal amphotericin B at a dosage 3mg/kg q.d will be given.\n* In case of renal function damage, combination with voriconazole 6mg/kg followed by 4 mg/kg b.i.d. will be given.', 'armGroupLabels': ['Caspofugin based combination therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ling Wang, M.D', 'role': 'CONTACT', 'phone': '86-21-64370045', 'phoneExt': '601818'}], 'facility': 'Blood & Marrow Transplantation Center, RuiJin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jiong HU, M.D.', 'role': 'CONTACT', 'email': 'hujiong@medmail.com.cn', 'phone': '86-21-64370045', 'phoneExt': '601818'}], 'overallOfficials': [{'name': 'Ling Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rui Jin Hospital, Shanghai JiaoTong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Jiong HU', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}