Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-27 @ 10:41 PM
Study NCT ID:
NCT00163761
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2005-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Outpatient Therapy for Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D007069', 'term': 'Ifosfamide'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-06', 'studyFirstSubmitDate': '2005-09-11', 'studyFirstSubmitQcDate': '2005-09-11', 'lastUpdatePostDateStruct': {'date': '2016-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy (overall response rate) of a risk-adjusted outpatient-based approach to lymphoma salvage therapy with VGF (vinorelbine, gemcitabine and pegfilgrastim) and/or F-GIV (gemcitabine, Ifosfamide, vinorelbine and pegfilgrastim).', 'timeFrame': 'After two cycles and after four cycles'}], 'secondaryOutcomes': [{'measure': 'To evaluate safety,', 'timeFrame': 'Days 1 and 8 for every cycle, days 10,12,14, and 16 for first cycle.'}, {'measure': 'relapse free survival,', 'timeFrame': 'After 2 cycles, 4 cyles and every 3 or 4 months for 12 months. Then every 6 months until disease progression'}, {'measure': 'overall survival,', 'timeFrame': 'every 3 or 4 months for 12 months. Then every 6 months.'}, {'measure': 'and planned dose-on-time.', 'timeFrame': 'After two cycles and after four cycles'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lymphoma'], 'conditions': ["Non-Hodgkin's Lymphoma", "Hodgkin's Disease"]}, 'descriptionModule': {'briefSummary': 'This is a Phase II trial evaluating the efficacy (overall response rate) of a risk-adjusted outpatient based approach to lymphoma salvage therapy with vinorelbine, gemcitabine and pegfilgrastim and/or gemcitabine, ifosfamide, vinorelbine and pegfilgrastim.', 'detailedDescription': "Lymphoma has been increasing in incidence annually for the past several decades and the majority of patients relapse after first line therapy. A variety of 'salvage chemotherapy' treatments are available that are usually inpatient-based treatments associated with significant haematological toxicity. Furthermore, all patients are treated in the same manner despite the fact that some patients will do well irrespective of the type of salvage therapy whereas others will do badly no matter what is done. During 2001-2002 we undertook a pilot study in 40 such patients using an outpatient-based salvage therapy with 2 newer chemotherapy drugs, vinorelbine and gemcitabine. Over 75% of all treatments were successfully delivered on an outpatient basis with response rates similar to historical controls. We now propose to expand on these initial findings by modifying the outpatient approach for those patients with less favourable prognostic features, that is, patients will be stratified to differing therapies but with the majority still receiving the proven vinorelbine-gemcitabine combination."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age \\> 18 years\n* relapsed or primary refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's Disease (HD)\n* ECOG 0 - 2\n* written informed consent\n\nExclusion criteria:\n\n* Intention to proceed with any form of transplant therapy following fewer than 2 cycles of protocol salvage therapy\n* bilirubin \\> 50μmol/litre unless secondary to lymphoma\n* creatinine \\> 2 x upper limit of normal unless secondary to lymphoma, absolute neutrophil count \\<0.5 x 109/litre and / or platelets \\< 50 x 109/litre unless secondary to lymphoma\n* relapse within 6 months of a prior transplant procedure (autologous or allogeneic)\n* known sensitivity to E coli derived preparations"}, 'identificationModule': {'nctId': 'NCT00163761', 'briefTitle': 'Efficacy Study of Outpatient Therapy for Lymphoma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bayside Health'}, 'officialTitle': 'A Multicentre Phase II Study of Risk-adjusted Outpatient-based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma', 'orgStudyIdInfo': {'id': 'AH226/02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Commence VGF treatment', 'description': 'Drug. Vinorelbine, gemcitabine and filgrastim 21 day cycle', 'interventionNames': ['Drug: gemcitabine, vinorelbine, filgastrim']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Commence F-GIV treatment', 'description': 'Drug. Gemcitabine, ifosfamide, Vinorelbine and filgrastim 21 day cycle', 'interventionNames': ['Drug: gemcitabine, vinorelbine, ifosfamide, filgastrim']}], 'interventions': [{'name': 'gemcitabine, vinorelbine, ifosfamide, filgastrim', 'type': 'DRUG', 'description': 'Drug', 'armGroupLabels': ['Commence F-GIV treatment']}, {'name': 'gemcitabine, vinorelbine, filgastrim', 'type': 'DRUG', 'description': 'Drug', 'armGroupLabels': ['Commence VGF treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2605', 'city': 'Canberra', 'state': 'Australian Capital Territory', 'country': 'Australia', 'facility': 'Canberra Hospital', 'geoPoint': {'lat': -35.28346, 'lon': 149.12807}}, {'zip': '2065', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal North Shore Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Mater Adult Hospital', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': '7001', 'city': 'Hobart', 'state': 'Tasmania', 'country': 'Australia', 'facility': 'Royal Hobart Hospital', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3050', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Royal Melbourne Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3199', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Frankston Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3199', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Medical Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3690', 'city': 'Wodonga', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Border Medical Oncology', 'geoPoint': {'lat': -36.12179, 'lon': 146.88809}}, {'zip': '6160', 'city': 'Fremantle', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Fremantle Hospital', 'geoPoint': {'lat': -32.05632, 'lon': 115.74557}}], 'overallOfficials': [{'name': 'Andrew Spencer, Assoc. Prof', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayside Health', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}