Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT00005867
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2000-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}], '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'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001761', 'term': 'Bleomycin'}, {'id': 'C036337', 'term': 'VAP-cyclo protocol'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D008942', 'term': 'Mitoxantrone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'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': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'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': '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-25', 'studyFirstSubmitDate': '2000-06-02', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival in patients treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP)'}], 'secondaryOutcomes': [{'measure': 'Failure-free survival, disease specific survival, relapse-free survival, death due to toxicity, response rate, and toxicity at 4 years'}]}, 'conditionsModule': {'keywords': ['stage I grade 3 follicular lymphoma', 'stage I adult diffuse mixed cell lymphoma', 'stage I adult diffuse large cell lymphoma', 'stage I adult immunoblastic large cell lymphoma', 'stage III grade 3 follicular lymphoma', 'stage III adult diffuse mixed cell lymphoma', 'stage III adult diffuse large cell lymphoma', 'stage III adult immunoblastic large cell lymphoma', 'stage IV grade 3 follicular lymphoma', 'stage IV adult diffuse mixed cell lymphoma', 'stage IV adult diffuse large cell lymphoma', 'stage IV adult immunoblastic large cell lymphoma', 'contiguous stage II grade 3 follicular lymphoma', 'contiguous stage II adult diffuse mixed cell lymphoma', 'contiguous stage II adult immunoblastic large cell lymphoma', 'contiguous stage II adult diffuse large cell lymphoma', 'noncontiguous stage II grade 3 follicular lymphoma', 'noncontiguous stage II adult diffuse mixed cell lymphoma', 'noncontiguous stage II adult immunoblastic large cell lymphoma', 'noncontiguous stage II adult diffuse large cell lymphoma'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for non-Hodgkin's lymphoma.\n\nPURPOSE: This randomized phase III trial is studying two regimens of combination chemotherapy and comparing how well they work in treating patients with aggressive non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\n* Compare the overall survival, failure free survival, disease specific survival, relapse free survival, and response rate in patients with aggressive non-Hodgkin's lymphoma treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP).\n* Compare the early and late toxicities of these regimens in these patients.\n\nOUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.\n\n* Arm I: Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1 and vincristine and bleomycin IV on day 8. Treatment continues every 14 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral prednisolone daily on courses 1 and 2 and every other day beginning on course 3 and continuing until the end of treatment.\n* Arm II: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed at 4 weeks, then every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 310 patients (155 per arm) will be accrued for this study over 5 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically proven previously untreated bulky stage IA or stage IB-IV aggressive non-Hodgkin's lymphoma of 1 of the following types:\n\n * Working formulation:\n\n * Follicular large cell\n * Diffuse mixed cell\n * Diffuse large cell\n * Diffuse immunoblastic OR\n * REAL classification:\n\n * Diffuse large B-cell\n * Peripheral T-cell\n* Measurable or evaluable disease\n* Good prognosis defined as no more than one of the following:\n\n * Stage III/IV disease\n * LDH greater than upper limit of normal\n * ECOG/WHO 2-4\n* No lymphoblastic or Burkitt's lymphoma\n* No CNS involvement\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 to 59\n\nPerformance status:\n\n* See Disease Characteristics\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Hemoglobin at least 10 g/dL\n* Neutrophil count at least 2,000/mm3\n* Platelet count at least 100,000/mm3\n\nHepatic:\n\n* Bilirubin, AST, and ALT no greater than 1.5 times upper limit of normal\n\nRenal:\n\n* Creatinine no greater than 1.7 mg/dL\n\nCardiovascular:\n\n* Ejection fraction at least 50% unless dysfunction attributable to lymphoma\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No other concurrent serious uncontrolled medical conditions\n* No other prior malignancy except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No prior chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior radiotherapy to more than 35% of hematopoietic sites\n* Concurrent consolidation radiotherapy allowed\n\nSurgery:\n\n* Not specified"}, 'identificationModule': {'nctId': 'NCT00005867', 'briefTitle': "Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma", 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': "Phase III Trial Comparing CHOP ot PMitCEBO in Good Risk Patients With Histologically Aggresive Non Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'BNLI-CHOPVPMITCEBO-GOODRISK'}, 'secondaryIdInfos': [{'id': 'CDR0000067900', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'EU-99052'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'bleomycin sulfate', 'type': 'BIOLOGICAL'}, {'name': 'CHOP regimen', 'type': 'DRUG'}, {'name': 'cyclophosphamide', 'type': 'DRUG'}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG'}, {'name': 'etoposide', 'type': 'DRUG'}, {'name': 'mitoxantrone hydrochloride', 'type': 'DRUG'}, {'name': 'prednisolone', 'type': 'DRUG'}, {'name': 'vincristine sulfate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HP21 8AL', 'city': 'Aylesbury-Buckinghamshire', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Stoke Mandeville Hospital'}, {'zip': 'OX16 9AL', 'city': 'Banbury', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Horton Hospital', 'geoPoint': {'lat': 52.0632, 'lon': -1.34222}}, {'zip': 'SS16 5NL', 'city': 'Basildon', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Basildon University Hospital', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'zip': 'B9 5SS', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Birmingham Heartlands Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BD9 6RJ', 'city': 'Bradford', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Bradford Hospitals NHS Trust', 'geoPoint': {'lat': 53.79391, 'lon': -1.75206}}, {'zip': 'BS2 8ED', 'city': 'Bristol', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Bristol Haematology and Oncology Centre', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'state': 'England', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'GL53 7AN', 'city': 'Cheltenham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cheltenham General Hospital', 'geoPoint': {'lat': 51.90006, 'lon': -2.07972}}, {'zip': 'CH2 1UL', 'city': 'Chester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Countess of Chester Hospital NHS Foundation Trust', 'geoPoint': {'lat': 53.1905, 'lon': -2.89189}}, {'zip': 'P019 4SE', 'city': 'Chichester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Saint Richards Hospital', 'geoPoint': {'lat': 50.83673, 'lon': -0.78003}}, {'zip': 'C03 3NB', 'city': 'Colchester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Essex County Hospital', 'geoPoint': {'lat': 51.88921, 'lon': 0.90421}}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Walsgrave Hospital', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'DY1 2HQ', 'city': 'Dudley', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Russells Hall Hospital', 'geoPoint': {'lat': 52.5, 'lon': -2.08333}}, {'zip': 'EN 28 JL', 'city': 'Enfield', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Chase Farm Hospital', 'geoPoint': {'lat': 51.65147, 'lon': -0.08497}}, {'zip': 'ME7 5NY', 'city': 'Gillingham Kent', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Medway Maritime Hospital'}, {'zip': 'HU3 2KZ', 'city': 'Hull', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Hull Royal Infirmary', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'PE18 6NT', 'city': 'Huntingdon', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Hinchingbrooke Hospital', 'geoPoint': {'lat': 52.33049, 'lon': -0.18651}}, {'zip': 'PE30 4ET', 'city': 'Kings Lynn', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 52.75172, 'lon': 0.39516}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Leicester Royal Infirmary', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Liverpool and Broadgreen Hospitals NHS Trust', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'L9 7AL', 'city': 'Liverpool', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Aintree University 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'Sheffield', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cancer Research Centre at Weston Park Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Southampton University Hospital NHS Trust', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'ST4 6QG', 'city': 'Stoke-On-Trent Staffs', 'state': 'England', 'country': 'United Kingdom', 'facility': 'University Hospital of North Staffordshire'}, {'zip': 'RH1 5RH', 'city': 'Surrey', 'state': 'England', 'country': 'United Kingdom', 'facility': 'East Surrey Hospital'}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Foundation Trust - Surrey', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'B71 4HJ', 'city': 'West Bromwich', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Sandwell General Hospital', 'geoPoint': {'lat': 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Kingdom', 'facility': 'University Hospital of Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'LL 18 5UJ', 'city': 'Rhyl, Denbighshire', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Glan Clywd District General Hospital', 'geoPoint': {'lat': 53.31929, 'lon': -3.49228}}, {'zip': 'LL 18 5UJ', 'city': 'Rhyl, Denbighshire', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Mount Vernon Cancer Centre at Mount Vernon Hospital', 'geoPoint': {'lat': 53.31929, 'lon': -3.49228}}], 'overallOfficials': [{'name': 'Ruth Pettengell, MD', 'role': 'STUDY_CHAIR', 'affiliation': "St. George's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lymphoma Trials Office', 'class': 'OTHER'}}}}