Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 2:52 PM
Study NCT ID:
NCT00079261
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2004-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Gemcitabine in Treating Patients With Previously Untreated 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': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D017728', 'term': 'Lymphoma, Large-Cell, Anaplastic'}, {'id': 'D007119', 'term': 'Immunoblastic Lymphadenopathy'}], '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'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D000072281', 'term': 'Lymphadenopathy'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C036337', 'term': 'VAP-cyclo protocol'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'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': 'D002241', 'term': 'Carbohydrates'}, {'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': 'D011244', 'term': 'Pregnadienediols'}, {'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': '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'lastUpdateSubmitDate': '2012-09-20', 'studyFirstSubmitDate': '2004-03-08', 'studyFirstSubmitQcDate': '2004-03-09', 'lastUpdatePostDateStruct': {'date': '2012-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response as assessed by Cheson criteria'}], 'secondaryOutcomes': [{'measure': 'Toxicity as assessed by CTC 2.0'}, {'measure': 'Proportion of courses given as scheduled'}, {'measure': 'Freedom from treatment failure as assessed by Cheson criteria'}]}, 'conditionsModule': {'keywords': ['contiguous stage II grade 3 follicular lymphoma', 'noncontiguous stage II grade 3 follicular lymphoma', 'stage III grade 3 follicular lymphoma', 'stage IV grade 3 follicular 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', 'anaplastic large cell lymphoma', 'angioimmunoblastic T-cell lymphoma', 'adult grade III lymphomatoid granulomatosis', 'small intestine lymphoma'], 'conditions': ['Lymphoma', 'Small Intestine Cancer']}, 'referencesModule': {'references': [{'pmid': '20942843', 'type': 'RESULT', 'citation': "Aurer I, Eghbali H, Raemaekers J, Khaled HM, Fortpied C, Baila L, van der Maazen RW; EORTC Lymphoma Group. Gem-(R)CHOP versus (R)CHOP: a randomized phase II study of gemcitabine combined with (R)CHOP in untreated aggressive non-Hodgkin's lymphoma--EORTC lymphoma group protocol 20021 (EudraCT number 2004-004635-54). Eur J Haematol. 2011 Feb;86(2):111-6. doi: 10.1111/j.1600-0609.2010.01540.x. Epub 2010 Dec 22."}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and gemcitabine, 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 randomized phase II trial is studying giving combination chemotherapy together with gemcitabine to see how well it works compared to giving combination chemotherapy alone in treating patients with previously untreated aggressive stage II, stage III, or stage IV non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\nPrimary\n\n* Compare the complete response rate (confirmed or unconfirmed) in patients with previously untreated aggressive non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone with vs without gemcitabine.\n\nSecondary\n\n* Compare the safety profile of these regimens in these patients.\n* Compare the feasibility of these regimens, defined as the proportion of courses given as scheduled, in these patients.\n* Compare freedom from treatment failure in patients treated with these regimens.\n\nOUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to participating center, International Prognostic Index score (0-2 vs 3-5), and histology (B cell vs T cell). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral or IV prednisone on days 1-5.\n* Arm II: Patients receive CHOP chemotherapy as in arm I and gemcitabine IV over 30 minutes on days 1 and 8.\n\nIn both arms, treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity or progressive disease. Patients achieving partial response or complete or unconfirmed complete response receive an additional 5 courses of therapy (for a total of 8 courses).\n\nPatients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 76-82 patients (38-41 per treatment arm) will be accrued for this study within 2 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of 1 of the following WHO subtypes:\n\n * Diffuse large B large cell lymphoma (including all clinical and morphologic variants)\n * Grade 3 follicular lymphoma\n * Extranodal T/NK cell lymphoma, nasal type\n * Enteropathy-type T cell lymphoma\n * Hepato-splenic T cell lymphoma\n * Peripheral T cell lymphoma, unspecified\n * Angioimmunoblastic lymphoma\n * Anaplastic large cell lymphoma, systemic type\n* Stage II-IV disease\n* At least 1 site of measurable disease (e.g., lymph node or lymph node mass)\n* The following subtypes are not allowed:\n\n * Mantle cell lymphoma\n * Burkitt's lymphoma\n * Precursor B or T cell lymphoma\n * Primary cutaneous B or T cell lymphoma\n* No CNS involvement by lymphoma\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* WBC \\> 3,000/mm\\^3\n* Neutrophil count \\> 1,000/mm\\^3\n* Platelet count \\> 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin \\< 2.5 times normal (unless due to lymphoma)\n* ALT and AST \\< 2.5 times normal (unless due to lymphoma)\n\nRenal\n\n* Creatinine \\< 2.0 mg/dL\n\nCardiovascular\n\n* No severe cardiac disease that would preclude study participation or limit life expectancy\n\nPulmonary\n\n* FEV\\_1 and DLCO ≥ 75% of predicted (unless due to lymphoma)\n* No severe pulmonary disease that would preclude study participation or limit life expectancy\n\nOther\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* HIV negative\n* No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix\n* No severe neurologic or metabolic disease that would preclude study participation or limit life expectancy\n* No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent monoclonal antibodies\n\nChemotherapy\n\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* No prior cytotoxic agents\n* No prior treatment for NHL\n* No other concurrent anticancer therapy\n* No other concurrent investigational drugs"}, 'identificationModule': {'nctId': 'NCT00079261', 'briefTitle': "Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Gemcitabine in Treating Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma", 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': "Gem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'EORTC-20021'}, 'secondaryIdInfos': [{'id': 'EORTC-20021'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'CHOP regimen', 'type': 'DRUG'}, {'name': 'cyclophosphamide', 'type': 'DRUG'}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG'}, {'name': 'gemcitabine hydrochloride', 'type': 'DRUG'}, {'name': 'prednisone', 'type': 'DRUG'}, {'name': 'vincristine sulfate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'U.Z. Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '2610', 'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Sint-Augustinus', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}, {'zip': '41000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'University Hospital Rebro', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'National Cancer Institute - Cairo', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': 'NL-6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum St. Radboud - Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Igor Aurer, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Rebro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}