Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-01-01 @ 4:16 AM
Study NCT ID:
NCT00262795
Status:
COMPLETED
Last Update Posted:
2019-05-23
First Post:
2005-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fludarabine or Chlorambucil as First-Line Therapy in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D002699', 'term': 'Chlorambucil'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-21', 'studyFirstSubmitDate': '2005-12-06', 'studyFirstSubmitQcDate': '2005-12-06', 'lastUpdatePostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage 0 chronic lymphocytic leukemia', 'stage I chronic lymphocytic leukemia', 'stage II chronic lymphocytic leukemia', 'stage III chronic lymphocytic leukemia', 'stage IV chronic lymphocytic leukemia'], 'conditions': ['Chronic Lymphocytic Leukemia']}, 'referencesModule': {'references': [{'pmid': '21139079', 'type': 'BACKGROUND', 'citation': 'Eichhorst BF, Fischer K, Fink AM, Elter T, Wendtner CM, Goede V, Bergmann M, Stilgenbauer S, Hopfinger G, Ritgen M, Bahlo J, Busch R, Hallek M; German CLL Study Group (GCLLSG). Limited clinical relevance of imaging techniques in the follow-up of patients with advanced chronic lymphocytic leukemia: results of a meta-analysis. Blood. 2011 Feb 10;117(6):1817-21. doi: 10.1182/blood-2010-04-282228. Epub 2010 Dec 7.'}, {'pmid': '24412156', 'type': 'BACKGROUND', 'citation': 'Cramer P, Bahlo J, Eichhorst B, Fischer K, Hallek M. Extramedullary manifestations of chronic lymphocytic leukaemia are not unusual. Leuk Res. 2014 Mar;38(3):284-5. doi: 10.1016/j.leukres.2013.11.015. Epub 2013 Dec 1. No abstract available.'}, {'pmid': '24584349', 'type': 'BACKGROUND', 'citation': 'Goede V, Cramer P, Busch R, Bergmann M, Stauch M, Hopfinger G, Stilgenbauer S, Dohner H, Westermann A, Wendtner CM, Eichhorst B, Hallek M; German CLL Study Group. Interactions between comorbidity and treatment of chronic lymphocytic leukemia: results of German Chronic Lymphocytic Leukemia Study Group trials. Haematologica. 2014 Jun;99(6):1095-100. doi: 10.3324/haematol.2013.096792. Epub 2014 Feb 28.'}, {'pmid': '31092457', 'type': 'BACKGROUND', 'citation': 'Sachanas S, Pangalis GA, Fink AM, Bahlo J, Fischer K, Levidou G, Kyrtsonis MC, Bartzi V, Vassilakopoulos TP, Kalpadakis C, Koulieris E, Moschogiannis M, Yiakoumis X, Tsirkinidis P, Angelopoulou MK, Eichhorst B, Hallek M. Small Lymphocytic Lymphoma: Analysis of Two Cohorts Including Patients in Clinical Trials of the German Chronic Lymphocytic Leukemia Study Group (GCLLSG) or in "Real-Life" Outside of Clinical Trials. Anticancer Res. 2019 May;39(5):2591-2598. doi: 10.21873/anticanres.13382.'}, {'pmid': '19605849', 'type': 'RESULT', 'citation': 'Eichhorst BF, Busch R, Stilgenbauer S, Stauch M, Bergmann MA, Ritgen M, Kranzhofer N, Rohrberg R, Soling U, Burkhard O, Westermann A, Goede V, Schweighofer CD, Fischer K, Fink AM, Wendtner CM, Brittinger G, Dohner H, Emmerich B, Hallek M; German CLL Study Group (GCLLSG). First-line therapy with fludarabine compared with chlorambucil does not result in a major benefit for elderly patients with advanced chronic lymphocytic leukemia. Blood. 2009 Oct 15;114(16):3382-91. doi: 10.1182/blood-2009-02-206185. Epub 2009 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as fludarabine and chlorambucil, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether fludarabine is more effective than chlorambucil in treating chronic lymphocytic leukemia.\n\nPURPOSE: This randomized phase III trial is studying fludarabine to see how well it works as first-line therapy compared to chlorambucil in treating older patients with previously untreated chronic lymphocytic leukemia.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the overall and progression-free survival of older patients with previously untreated chronic lymphocytic leukemia treated with fludarabine vs chlorambucil.\n* Compare the duration of remission in patients treated with these regimens.\n\nSecondary\n\n* Compare the incidence of toxicity, especially infections, in patients treated with these regimens.\n* Compare the quality of life in patients treated with these regimens.\n\nOUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive fludarabine IV on days 1-5. Treatment repeats every 28 days for up to 6 courses.\n* Arm II: Patients receive oral chlorambucil on day 1. Treatment repeats every 15 days for up to 12 months.\n\nPROJECTED ACCRUAL: A total of 205 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Confirmed diagnosis of chronic lymphocytic leukemia, meeting any of the following staging criteria:\n\n * Binet stage A with B symptoms\n * Binet stage B or C, meeting 1 of the following criteria:\n\n * Rapid disease progression\n * Enlarged lymph nodes and organs\n * Severe B symptoms\n* Previously untreated disease\n\nPATIENT CHARACTERISTICS:\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* More than 6 months\n\nHematopoietic\n\n* No thrombocytopenia\n* No autoimmune hemolytic anemia\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nOther\n\n* No severe organ dysfunction\n* No other prior or concurrent neoplasm\n\nPRIOR CONCURRENT THERAPY:\n\nChemotherapy\n\n* No prior chemotherapy\n* No other concurrent chemotherapy'}, 'identificationModule': {'nctId': 'NCT00262795', 'briefTitle': 'Fludarabine or Chlorambucil as First-Line Therapy in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'German CLL Study Group'}, 'officialTitle': 'Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia', 'orgStudyIdInfo': {'id': 'CLL5'}, 'secondaryIdInfos': [{'id': 'EU-20557'}, {'id': 'MEDAC-GCLLSG-CLL5'}, {'id': 'GCLLSG-73'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'F', 'description': 'Fludarabine', 'interventionNames': ['Drug: Fludarabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CLB', 'description': 'Chlorambucil', 'interventionNames': ['Drug: Chlorambucil']}], 'interventions': [{'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles', 'armGroupLabels': ['F']}, {'name': 'Chlorambucil', 'type': 'DRUG', 'description': 'Chlorambucil p.o. (0,4 mg - max. 0,8 mg/kg/d, d1) q15d, max. 12 month', 'armGroupLabels': ['CLB']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-1140', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Hanuschkrankenhaus', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'D-92224', 'city': 'Amberg', 'country': 'Germany', 'facility': 'Klinikum St. Marien', 'geoPoint': {'lat': 49.44287, 'lon': 11.86267}}, {'zip': '91522', 'city': 'Ansbach', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie', 'geoPoint': {'lat': 49.30481, 'lon': 10.5931}}, {'zip': 'DOH-86156', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Zentralklinikum Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '15526', 'city': 'Bad Saarow', 'country': 'Germany', 'facility': 'Humaine - Clinic', 'geoPoint': {'lat': 52.28333, 'lon': 14.06667}}, {'zip': '95445', 'city': 'Bayreuth', 'country': 'Germany', 'facility': 'Krankenhaus Hohe Warte Mediziniche Klinik', 'geoPoint': {'lat': 49.94782, 'lon': 11.57893}}, {'zip': '10249', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Onkologisches Versorgungszentrum Friedrichshain', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14195', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Internistische Gemeinschaftspraxis - Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-12200', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite - Campus Virchow Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Saint Josef - Hospital Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '28205', 'city': 'Bremen', 'country': 'Germany', 'facility': 'Praxis Dres. F.& G. 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