Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT01333605
Status:
UNKNOWN
Last Update Posted:
2013-03-05
First Post:
2011-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IGEV Followed by Autologous Transplantation for Refractory or Relapsed Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 43}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-02', 'studyFirstSubmitDate': '2011-04-11', 'studyFirstSubmitQcDate': '2011-04-11', 'lastUpdatePostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response rate', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '6 weeks'}, {'measure': '3-year progression-free survival rate', 'timeFrame': '3 years'}, {'measure': '3-year overall survival rate', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hodgkin lymphoma', 'Chemotherapy', 'IGEV', 'Autologous stem cell transplantation'], 'conditions': ['Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'The aim of study is to prove IGEV regimen followed by autologous stem cell transplantation as salvage treatment in patients with refractory or relapsed Hodgkin lymphoma is effective.', 'detailedDescription': 'The standard treatment in patients with refractory or relapsed Hodgkin lymphoma is salvage chemotherapy followed by autologous transplantation for responsive patients. However, the standard of salvage chemotherapy remains uncertain. This study is to evaluate the efficacy and safety of IGEV regimen in a single-center basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range: 18-65 years old\n* Histological confirmed refractory or relapsed Hodgkin lymphoma\n* With at least one site of measurable disease according to IWC criteria\n* ECOG performance status 0-1\n* Life expectancy of more than 3 months\n* Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L\n* Liver function: total bilirubin, ALT and AST \\<1.5×UNL\n* Renal function: Cr\\<1.5×UNL, CCR≧45ml/min\n* No contraindication for transplantation\n\nExclusion Criteria:\n\n* No prior chemotherapy\n* With more than 2 lines of prior chemotherapy exposure\n* Evidence of CNS and bone marrow involvement\n* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix\n* Pregnant or lactating women\n* Significant active infection'}, 'identificationModule': {'nctId': 'NCT01333605', 'briefTitle': 'IGEV Followed by Autologous Transplantation for Refractory or Relapsed Hodgkin Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Phase II Study of IGEV Followed by Autologous Stem Cell Transplantation in Patients With Refractory or Relapsed Hodgkin Lymphoma.', 'orgStudyIdInfo': {'id': 'LMTG 11-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IGEV regimen', 'description': 'Ifosfamide 1200 mg/m2 at days 1-4, Mesna 400 mg 0,4,8h at days 1-4, Gemcitabine 800 mg/m2 at day 1 and day 4, Vinorelbine 20 mg/m2 at day 1, Prednisone 100 mg at days 1-4. Frequency of cycles: every 3 weeks. Numbers of cycles: 4 cycles', 'interventionNames': ['Drug: IGEV']}], 'interventions': [{'name': 'IGEV', 'type': 'DRUG', 'description': 'Ifosfamide 1200 mg/m2 at days 1-4, Mesna 400 mg 0,4,8h at days 1-4, Gemcitabine 800 mg/m2 at day 1 and day 4, Vinorelbine 20 mg/m2 at day 1, Prednisone 100 mg at days 1-4. Frequency of cycles: every 3 weeks. Numbers of cycles: 4 cycles.', 'armGroupLabels': ['IGEV regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ye Guo, MD', 'role': 'CONTACT', 'email': 'pattrick_guo@msn.com', 'phone': '86 21 64175590', 'phoneExt': '8906'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ye Guo, MD', 'role': 'CONTACT', 'email': 'pattrick_guo@msn.com', 'phone': '86 21 64175590', 'phoneExt': '8906'}], 'overallOfficials': [{'name': 'Ye Guo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Ye Guo', 'investigatorAffiliation': 'Fudan University'}}}}