Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-31 @ 10:17 AM
Study NCT ID:
NCT00079105
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2004-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}], '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': 'D001761', 'term': 'Bleomycin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'C061400', 'term': 'etoposide phosphate'}, {'id': 'D008942', 'term': 'Mitoxantrone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'C009022', 'term': 'prednisolone phosphate'}, {'id': 'D011344', 'term': 'Procarbazine'}, {'id': 'D014747', 'term': 'Vinblastine'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'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': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-29', 'studyFirstSubmitDate': '2004-03-08', 'studyFirstSubmitQcDate': '2004-03-08', 'lastUpdatePostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival by routine imaging', 'timeFrame': '6 month intervals'}], 'secondaryOutcomes': [{'measure': 'Overall survival by routine imaging', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage I adult Hodgkin lymphoma', 'stage II adult Hodgkin lymphoma', 'stage III adult Hodgkin lymphoma', 'stage IV adult Hodgkin lymphoma'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy, such as vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells.\n\nPURPOSE: This phase II trial is studying how well combination chemotherapy works in treating older patients with previously untreated Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\nPrimary\n\n* Determine the efficacy and toxicity of vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin in older patients with Hodgkin's lymphoma.\n* Determine whether the application of the Hasenclever prognostic index is valid in these patients at diagnosis.\n\nOUTLINE: This is an open-label, multicenter study.\n\n* Chemotherapy: Patients receive vinblastine IV and cyclophosphamide IV on day 1; oral procarbazine and oral prednisolone on days 1-5; oral etoposide on days 15-19; and mitoxantrone IV and bleomycin IV on day 15. Treatment repeats every 28 days, in the absence of disease progression or unacceptable toxicity, for a total of 3 courses in patients with early (stage IA or IIA) disease or 6 courses in patients with advanced (stage IB or IIB-IV) disease.\n* Radiotherapy: Patients with early stage disease receive involved-field radiotherapy. Patients with advanced stage disease receive radiotherapy limited to sites of initial bulky disease or residual disease. Radiotherapy begins 4 weeks after the completion of chemotherapy.\n\nPatients are followed monthly for 3 months, every 3 months for 6 months, and then annually thereafter.\n\nPeer Reviewed and Funded or Endorsed by Cancer Research UK\n\nPROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 36 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nHistologically confirmed classical Hodgkin Lymphoma (HL). No previous treatment for HL. Age ≥ 60. "Non fragile" patient (see Appendix 1) i.e. patient\'s mental and physical status must be sufficient to withstand the treatment described.\n\nNo concomitant neoplasia requiring treatment or known HIV infection. Written informed consent.\n\nExclusion criteria:\n\nNodular lymphocyte predominance Hodgkin Lymphoma (NLPHL) Age \\<60. Patient previously treated for HL. Known HIV infection or concomitant neoplasia. "Fragile patient" (see Appendix 1) or significant abnormality of another system (pulmonary, cardiac, renal, and hepatic) which is a contraindication to full dose chemotherapy.\n\nUnable to give informed consent.'}, 'identificationModule': {'nctId': 'NCT00079105', 'briefTitle': "A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years", 'organization': {'class': 'OTHER', 'fullName': 'Newcastle-upon-Tyne Hospitals NHS Trust'}, 'officialTitle': "A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years; Vinblastine, Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone, and Bleomycin in Treating Older Patients With Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'CDR0000354225'}, 'secondaryIdInfos': [{'id': 'UON-SHIELD', 'type': 'OTHER', 'domain': 'Sponsor'}, {'id': 'EU-20346', 'type': 'OTHER', 'domain': 'Sponsor'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment', 'description': 'Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate', 'interventionNames': ['Biological: bleomycin sulfate', 'Drug: cyclophosphamide', 'Drug: etoposide', 'Drug: mitoxantrone hydrochloride', 'Drug: prednisolone', 'Drug: procarbazine hydrochloride', 'Drug: vinblastine sulfate']}, {'type': 'NO_INTERVENTION', 'label': 'Registration', 'description': 'Registration, without treatment'}], 'interventions': [{'name': 'bleomycin sulfate', 'type': 'BIOLOGICAL', 'otherNames': ['Blenoxane'], 'description': 'Treatment', 'armGroupLabels': ['Treatment']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cytoxan'], 'description': 'Treatment', 'armGroupLabels': ['Treatment']}, {'name': 'etoposide', 'type': 'DRUG', 'otherNames': ['Eposin', 'Etopophos', 'Vepesid'], 'description': 'Treatment', 'armGroupLabels': ['Treatment']}, {'name': 'mitoxantrone hydrochloride', 'type': 'DRUG', 'otherNames': ['Novantrone'], 'description': 'Treatment', 'armGroupLabels': ['Treatment']}, {'name': 'prednisolone', 'type': 'DRUG', 'otherNames': ['Flo-Pred', 'Pediapred', 'Orapred'], 'description': 'Treatment', 'armGroupLabels': ['Treatment']}, {'name': 'procarbazine hydrochloride', 'type': 'DRUG', 'otherNames': ['Matulane'], 'description': 'Treatment', 'armGroupLabels': ['Treatment']}, {'name': 'vinblastine sulfate', 'type': 'DRUG', 'otherNames': ['Vincristine'], 'description': 'Treatment', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-50924', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Medizinische Universitaetsklinik I at the University of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': 'NE63 9JJ', 'city': 'Ashington', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Wansbeck General Hospital', 'geoPoint': {'lat': 55.17719, 'lon': -1.56412}}, {'zip': 'RG24 9NA', 'city': 'Basingstoke', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Basingstoke and North Hampshire NHS Foundation Trust', 'geoPoint': {'lat': 51.26249, 'lon': -1.08708}}, {'zip': 'BA1 3NG', 'city': 'Bath', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal United Hospital', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'zip': 'B75 7RR', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Good Hope Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'FY3 8NR', 'city': 'Blackpool', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Blackpool Victoria Hospital', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'zip': 'BH7 7DW', 'city': 'Bournemouth', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth Hospital', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'BD9 6RJ', 'city': 'Bradford', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Bradford Royal Infirmary', 'geoPoint': 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'Stoke-On-Trent Staffs', 'state': 'England', 'country': 'United Kingdom', 'facility': 'University Hospital of North Staffordshire'}, {'zip': 'SR4 7TP', 'city': 'Sunderland', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Sunderland Royal Hospital', 'geoPoint': {'lat': 54.90465, 'lon': -1.38222}}, {'zip': 'TR1 3LJ', 'city': 'Truro, Cornwall', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Cornwall Hospital', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}, {'zip': 'CA28 8JG', 'city': 'Whitehaven', 'state': 'England', 'country': 'United Kingdom', 'facility': 'West Cumberland Hospital', 'geoPoint': {'lat': 54.54897, 'lon': -3.58412}}, {'zip': 'Y031 8HE', 'city': 'York', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cancer Care Centre at York Hospital', 'geoPoint': {'lat': 53.95763, 'lon': -1.08271}}, {'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'ML6 0JF', 'city': 'Airdrie', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Monklands General Hospital', 'geoPoint': {'lat': 55.86602, 'lon': -3.98025}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Edinburgh Cancer Centre at Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'G11 6NT', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Western Infirmary', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': '1V2 3UJ', 'city': 'Inverness', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Raigmore Hospital', 'geoPoint': {'lat': 57.47908, 'lon': -4.22398}}, {'city': 'Paisley', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 55.83173, 'lon': -4.43254}}, {'zip': 'ML2 0DP', 'city': 'Wishaw', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Wishaw General Hospital', 'geoPoint': {'lat': 55.76667, 'lon': -3.91667}}, {'zip': 'EN5 3DJ', 'city': 'Barnet, Hertfordshire', 'country': 'United Kingdom', 'facility': 'Barnet General Hospital', 'geoPoint': {'lat': 51.65, 'lon': -0.2}}], 'overallOfficials': [{'name': 'Stephen J. Proctor, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Newcastle Upon-Tyne'}, {'name': 'Helen H. Lucraft, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Northern Centre for Cancer Treatment at Newcastle General Hospital'}, {'name': 'Katrina M. Wood, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sir James Spence Institute of Child Health at Royal Victoria Infirmary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD were shared, nor will be, for this trial.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Newcastle-upon-Tyne Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}