Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT00064116
Status:
COMPLETED
Last Update Posted:
2020-04-01
First Post:
2003-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy With or Without Rituximab in Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], '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'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'C036337', 'term': 'VAP-cyclo protocol'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 824}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2014-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2003-07-08', 'studyFirstSubmitQcDate': '2003-07-08', 'lastUpdatePostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to treatment failure (TTF) at 3 years', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Complete remission rate after completion of treatment', 'timeFrame': '3 years'}, {'measure': 'Overall survival at 3 years', 'timeFrame': '3 years'}, {'measure': 'Tumor control measured by TTF with non-tumor events censored at 3 years', 'timeFrame': '3 years'}, {'measure': 'Disease-free survival (DFS) measured by TTF after an event during and directly after treatment at 3 years', 'timeFrame': '3 years'}, {'measure': 'Progression rate determined by dividing the number of patients with disease progression by number of patients with evaluable outcome at 3 years', 'timeFrame': '3 years'}, {'measure': 'Time to progression measured at 3 years', 'timeFrame': '3 years'}, {'measure': 'Toxicity assessed by NCI CTC v2.0 after completion of treatment', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stage I adult diffuse large cell lymphoma', 'contiguous stage II adult diffuse large cell lymphoma', 'noncontiguous stage II adult diffuse large cell lymphoma', 'stage III adult diffuse large cell lymphoma', 'stage IV adult diffuse large cell lymphoma'], 'conditions': ['Lymphoma']}, 'referencesModule': {'references': [{'pmid': '18400558', 'type': 'RESULT', 'citation': 'Pfreundschuh M, Ho AD, Cavallin-Stahl E, Wolf M, Pettengell R, Vasova I, Belch A, Walewski J, Zinzani PL, Mingrone W, Kvaloy S, Shpilberg O, Jaeger U, Hansen M, Corrado C, Scheliga A, Loeffler M, Kuhnt E; MabThera International Trial (MInT) Group. Prognostic significance of maximum tumour (bulk) diameter in young patients with good-prognosis diffuse large-B-cell lymphoma treated with CHOP-like chemotherapy with or without rituximab: an exploratory analysis of the MabThera International Trial Group (MInT) study. Lancet Oncol. 2008 May;9(5):435-44. doi: 10.1016/S1470-2045(08)70078-0. Epub 2008 Apr 8.'}, {'pmid': '16648042', 'type': 'RESULT', 'citation': 'Pfreundschuh M, Trumper L, Osterborg A, Pettengell R, Trneny M, Imrie K, Ma D, Gill D, Walewski J, Zinzani PL, Stahel R, Kvaloy S, Shpilberg O, Jaeger U, Hansen M, Lehtinen T, Lopez-Guillermo A, Corrado C, Scheliga A, Milpied N, Mendila M, Rashford M, Kuhnt E, Loeffler M; MabThera International Trial Group. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006 May;7(5):379-91. doi: 10.1016/S1470-2045(06)70664-7.'}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without rituximab in treating patients with non-Hodgkin's lymphoma.\n\nPURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens and rituximab to see how well they work compared to four different combination chemotherapy regimens alone in treating patients with non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\n* Compare the time to treatment failure in patients with CD20-positive diffuse large B-cell non-Hodgkin's lymphoma treated with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)-like chemotherapy with vs without rituximab.\n* Compare the tumor control, progression rate, and complete remission rate in patients treated with these regimens.\n* Compare the disease-free and overall survival rate of patients treated with these regimens.\n* Compare the toxicity of these regimens in these patients.\n\nOUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, bulky disease (no vs yes), International Prognostic Index score (0 vs 1), and chemotherapy (CHOP vs CHOEP vs PMitCEBO vs MACOP-B). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive 1 of the following chemotherapy regimens according to participating country:\n\n * CHOP: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone or prednisolone on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n * CHOEP-21: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; etoposide IV on days 1-3; and oral prednisone on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n * PMitCEBO: Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1; vincristine IV and bleomycin IV on day 8; and oral prednisolone daily during weeks 1-4 and every other day during week 5. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n * MACOP-B: Patients receive cyclophosphamide IV and doxorubicin IV on days 1, 15, 29, 43, 57, and 71; methotrexate IV and vincristine IV on days 8, 36, and 64; bleomycin IV and vincristine IV on days 22, 50, and 78; and oral or intramuscular prednisone on days 1-84. Treatment continues in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients receive arm I regimens (according to participating country) and rituximab as follows:\n\n * CHOP and rituximab: Patients receive CHOP as in arm I and rituximab IV on day 1.\n * CHOEP-21 and rituximab: Patients receive CHOEP-21 as in arm I and rituximab IV on day 1.\n * PMitCEBO and rituximab: Patients receive PMitCEBO as in arm I and rituximab IV on day 1 during courses 1 and 4; on day 8 during courses 2 and 5; and on day 1 at 1 and 4 weeks after completion of the last course of PMitCEBO chemotherapy.\n * MACOP-B and rituximab: Patients receive MACOP-B as in arm I and rituximab IV on days 1, 22, 43, 64, 85, and 106.\n\nPatients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 820 patients will be accrued for this study within approximately 2 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma according to REAL classification\n\n * Diagnosed within the past 6 weeks\n * CD20+ disease\n * Ann Arbor stage II, III, or IV disease or stage I bulky disease\n* International Prognostic Index (IPI) score of 0 or 1\n\n * Score 0 defined by all of the following:\n\n * Stage I or II disease\n * ECOG performance status of 0 or 1\n * Lactic dehydrogenase (LDH) no greater than upper limit of normal (ULN)\n * Score 1 defined by 1 of the following:\n\n * Stage I or II disease; ECOG performance status of 0 or 1; and LDH greater than ULN\n * Stage I or II disease; ECOG performance status 2 or 3; and LDH no greater than ULN\n * Stage III or IV disease; ECOG performance status 0 or 1; and LDH no greater than ULN\n* Previously untreated disease\n* Mediastinal B-cell lymphoma allowed\n* No secondary lymphoma after prior chemotherapy or radiotherapy for other malignancies\n* No transformed lymphoma\n* No primary CNS lymphoma\n* No primary gastrointestinal (MALT) lymphoma\n* No post-transplant lymphoproliferative disorder\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 to 60\n\nPerformance status\n\n* See Disease Characteristics\n* ECOG 0-3\n\nLife expectancy\n\n* At least 3 months\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Bilirubin no greater than 2.0 mg/dL\\*\n* Transaminases no greater than 3 times normal\\*\n* No active chronic hepatitis B or C infection NOTE: \\*Unless related to lymphoma\n\nRenal\n\n* Creatinine no greater than 2 times normal\\* NOTE: \\*Unless related to lymphoma\n\nCardiovascular\n\n* No myocardial infarction within the past 6 months\n* No uncompensated heart failure\n* No dilatative cardiomyopathy\n* No coronary heart disease with ST segment depression on ECG\n* No severe uncompensated hypertension\n\nPulmonary\n\n* No chronic lung disease with hypoxemia\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* HIV negative\n* No known allergic reactions against foreign proteins\n* No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix\n* No concurrent disease that would preclude study treatment\n* No active infections requiring systemic antibiotics or antiviral medications\n* No severe uncompensated diabetes mellitus\n* No clinical signs of cerebral dysfunction\n* No severe psychiatric disease\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior murine antibodies\n\nChemotherapy\n\n* No other concurrent anticancer chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No concurrent response-adapted (slow response or unconfirmed complete response) radiotherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* No prior lymphoma-specific treatment\n* More than 12 weeks since prior participation in another clinical trial\n* No prior participation in this study\n* No other concurrent study medication"}, 'identificationModule': {'nctId': 'NCT00064116', 'acronym': 'IDEC-C2B8', 'briefTitle': "Combination Chemotherapy With or Without Rituximab in Non-Hodgkin's Lymphoma", 'organization': {'class': 'NETWORK', 'fullName': 'Canadian Cancer Trials Group'}, 'officialTitle': "Randomized Intergroup Trial of First Line Treatment for Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma With a CHOP-Like Chemotherapy Regimen With or Without the Anti-CD20 Antibody Rituximab", 'orgStudyIdInfo': {'id': 'LY9'}, 'secondaryIdInfos': [{'id': 'CAN-NCIC-LY9'}, {'id': 'ROCHE-CAN-NCIC-LY9', 'type': 'OTHER', 'domain': 'Roche'}, {'id': 'MINT-M39045'}, {'id': 'CDR0000309053', 'type': 'OTHER', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A: CHOP-21', 'description': 'Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle: day 22 Total number of cycles 6', 'interventionNames': ['Drug: CHOP regimen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B: CHOP-21 + Rituximab', 'description': 'Rituximab 375 mg/m² i.v. day 1\\* Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle day 22 Total number of cycles: 6', 'interventionNames': ['Biological: rituximab', 'Drug: CHOP regimen']}], 'interventions': [{'name': 'rituximab', 'type': 'BIOLOGICAL', 'description': 'Rituximab 375 mg/m² i.v. day 1', 'armGroupLabels': ['Arm B: CHOP-21 + Rituximab']}, {'name': 'CHOP regimen', 'type': 'DRUG', 'description': 'Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle day 22 Total number of cycles: 6', 'armGroupLabels': ['Arm A: CHOP-21', 'Arm B: CHOP-21 + Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'R3E 0V9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'CancerCare Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'E1C 6Z8', 'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'The Moncton Hospital', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'zip': 'AIB 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Dr. H. Bliss Murphy Cancer Centre', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'QEII Health Sciences Center', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'K7L 5P9', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cancer Centre of Southeastern Ontario at Kingston', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'N2G 1G3', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Grand River Regional Cancer Centre', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Regional Cancer Program', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Health Research Institute - General Division', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'L2R 7C6', 'city': 'St. Catharines', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Niagara Health System', 'geoPoint': {'lat': 43.17126, 'lon': -79.24267}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Odette Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Univ. Health Network-The Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Univ. Health Network-Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M9C 1A5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Trillium Health Centre - West Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'C1A 8T5', 'city': 'Charlottetown', 'state': 'Prince Edward Island', 'country': 'Canada', 'facility': 'PEI Cancer Treatment Centre,Queen Elizabeth Hospital', 'geoPoint': {'lat': 46.23459, 'lon': -63.1256}}, {'zip': 'J4V 2H1', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Charles LeMoyne', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Maisonneuve-Rosemont', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUM - Hopital Notre-Dame', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University - Dept. Oncology', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital du Sacre-Coeur de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1S 4L8', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHA-Hopital Du St-Sacrement', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre hospitalier universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'S4T 7T1', 'city': 'Regina', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Allan Blair Cancer Centre', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}, {'zip': 'S7N 4H4', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Saskatoon Cancer Centre', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Kevin Imrie, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Toronto Sunnybrook Regional Cancer Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NCIC Clinical Trials Group', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}