Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-27 @ 3:11 AM
Study NCT ID:
NCT00006250
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2000-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV 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'}], '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': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002699', 'term': 'Chlorambucil'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C042382', 'term': 'fludarabine phosphate'}, {'id': 'D008942', 'term': 'Mitoxantrone'}], 'ancestors': [{'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': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011809', 'term': 'Quinones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2000-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'lastUpdateSubmitDate': '2013-09-19', 'studyFirstSubmitDate': '2000-09-11', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to treatment failure'}, {'measure': 'Progression-free survival rate'}, {'measure': 'Overall survival rate'}], 'secondaryOutcomes': [{'measure': 'Clinical remission rate'}, {'measure': 'Molecular remission rate'}]}, 'conditionsModule': {'keywords': ['stage III grade 1 follicular lymphoma', 'stage III grade 2 follicular lymphoma', 'stage III grade 3 follicular lymphoma', 'stage IV grade 1 follicular lymphoma', 'stage IV grade 2 follicular lymphoma', 'stage IV grade 3 follicular 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 combination chemotherapy regimen is more effective for non-Hodgkin's lymphoma.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\n* Compare the overall survival rate, progression free survival rate, clinical and molecular remission rates, and time to treatment failure in patients with newly diagnosed stage III or IV follicular non-Hodgkin's lymphoma treated with chlorambucil, mitoxantrone, and dexamethasone versus fludarabine, mitoxantrone, and dexamethasone.\n* Compare the efficacy and tolerability of these regimens in these patients.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to International Prognostic Index score \\[low risk (score 1) vs intermediate low risk (score 2) vs intermediate high risk (score 3) vs high risk (score 4 or 5)\\]. Patients are randomized to one of two treatment arms.\n\n* Arm I: Patients receive mitoxantrone IV on day 1, oral chlorambucil on days 1-10, and oral dexamethasone on days 1-5.\n* Arm II: Patients receive mitoxantrone and dexamethasone as in arm I and fludarabine IV on days 1-3.\n\nTreatment continues every 4 weeks for 4-8 courses.\n\nPatients are followed at 3, 6, and 12 months, every 6 months for 1 year, and then annually thereafter until clinical relapse.\n\nPROJECTED ACCRUAL: A total of 500 patients (250 per arm) will be accrued for this study within 4 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically proven newly diagnosed stage III or IV follicular non-Hodgkin's lymphoma\n\n * REAL classification grade I, II, or III\n* Treatment necessity indicated by presence of the following:\n\n * B symptoms\n * Bone marrow failure\n * Bulky or progressive disease\n * Compression syndromes\n* No CNS involvement\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 to 70\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* No autoimmune hemolytic anemia or active hemolysis\n* Direct Coombs' negative\n\nHepatic:\n\n* Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN)\\*\n* Bilirubin no greater than 2.5 times ULN\\* NOTE: \\*Unless attributable to lymphoma\n\nRenal:\n\n* Creatinine no greater than 2.5 times ULN (unless attributable to lymphoma)\n\nCardiovascular:\n\n* No severe cardiac failure\n* Ejection fraction at least 45%\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception during and for at least 6 months after study\n* HIV negative\n* No prior malignancy except carcinoma in situ of the cervix or squamous cell skin cancer\n* No other serious medical disease that would limit lifespan or ability to tolerate chemotherapy\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Not specified\n\nEndocrine therapy:\n\n* No concurrent systemic corticosteroids\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No prior therapy"}, 'identificationModule': {'nctId': 'NCT00006250', 'briefTitle': "Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma", 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma', 'orgStudyIdInfo': {'id': 'CDR0000068182'}, 'secondaryIdInfos': [{'id': 'BNLI-MCD/FMD'}, {'id': 'EU-20035'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'chlorambucil', 'type': 'DRUG'}, {'name': 'dexamethasone', 'type': 'DRUG'}, {'name': 'fludarabine phosphate', 'type': 'DRUG'}, {'name': 'mitoxantrone hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HP21 8AL', 'city': 'Aylesbury-Buckinghamshire', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Stoke Mandeville Hospital'}, {'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': 'CT2 7NR', 'city': 'Canterbury', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Kent and Canterbury Hospital', 'geoPoint': {'lat': 51.27904, 'lon': 1.07992}}, {'zip': 'SM5 1AA', 'city': 'Carshalton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'St Helier Hospital', 'geoPoint': {'lat': 51.36829, 'lon': -0.16755}}, {'zip': 'P019 4SE', 'city': 'Chichester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Saint Richards Hospital', 'geoPoint': {'lat': 50.83673, 'lon': -0.78003}}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Walsgrave Hospital', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'DA1 5PL', 'city': 'Dartford Kent', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Dartford & Gravesham NHS Trust, Joyce Green Hospital'}, {'zip': 'DE1 2QY', 'city': 'Derby', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Derbyshire Royal Infirmary', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'zip': 'DN2 5LT', 'city': 'Doncaster', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Doncaster Royal Infirmary', 'geoPoint': {'lat': 53.52285, 'lon': -1.13116}}, {'zip': 'DY1 2HQ', 'city': 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'city': 'Ipswich', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Ipswich Hospital NHS Trust', 'geoPoint': {'lat': 52.05917, 'lon': 1.15545}}, {'zip': 'TW7 6AF', 'city': 'Isleworth', 'state': 'England', 'country': 'United Kingdom', 'facility': 'West Middlesex University Hospital', 'geoPoint': {'lat': 51.47518, 'lon': -0.34246}}, {'zip': 'NNI6 8UZ', 'city': 'Kettering, Northants', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Kettering General Hosptial', 'geoPoint': {'lat': 52.39836, 'lon': -0.72571}}, {'zip': 'PE30 4ET', 'city': 'Kings Lynn', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 52.75172, 'lon': 0.39516}}, {'zip': 'LS2 9N9', 'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Clinical Trials and Research Unit of the University of Leeds', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'England', 'country': 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'state': 'England', 'country': 'United Kingdom', 'facility': 'Oldchurch Hospital', 'geoPoint': {'lat': 51.57515, 'lon': 0.18582}}, {'zip': 'S60 2UD', 'city': 'Rotherham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Rotherham District General Hospital - NHS Trust', 'geoPoint': {'lat': 53.43012, 'lon': -1.35678}}, {'zip': 'TN2 4QJ', 'city': 'Royal Tunbridge Wells, Kent', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Pembury Hospital'}, {'zip': 'DN15 7BH', 'city': 'Scunthorpe', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Scunthorpe General Hospital', 'geoPoint': {'lat': 53.57905, 'lon': -0.65437}}, {'zip': 'S1O 2JF', 'city': 'Sheffield', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Hallamshire Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'S1O 2SJ', 'city': 'Sheffield', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cancer Research Centre at Weston Park Hospital', 'geoPoint': 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'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': 'SA2 8QA', 'city': 'Swansea', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Singleton Hospital of the Swansea NHS Trust', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}], 'overallOfficials': [{'name': 'Andy Haynes, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nottingham City Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lymphoma Trials Office', 'class': 'OTHER'}}}}