Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-04 @ 12:54 PM
Study NCT ID:
NCT00281892
Status:
COMPLETED
Last Update Posted:
2018-05-11
First Post:
2006-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fludarabine and Darbepoetin Alfa in Treating Older Patients With Chronic Lymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D000740', 'term': 'Anemia'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-09', 'studyFirstSubmitDate': '2006-01-24', 'studyFirstSubmitQcDate': '2006-01-24', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free survival', 'timeFrame': 'up to 24 months after the last dose of study medication', 'description': 'defined as the time from initial randomization/stratification to the time-point of progressive disease, new therapy, or death)'}], 'secondaryOutcomes': [{'measure': 'Response Rate', 'timeFrame': '2 months after the end of the last cycle', 'description': 'Restaging after the end of treatment included evaluation of the peripheral blood and physical examination; use of imaging techniques (ultrasound and conventional radiography or computertomography) and evaluation of the bone marrow were mandatory to assign a complete remission'}, {'measure': 'toxicity', 'timeFrame': '28 days after the end of the last cycle', 'description': 'adverse events were reported according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC version 2.0).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anemia', 'refractory chronic lymphocytic leukemia', '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', 'Anemia']}, 'referencesModule': {'references': [{'pmid': '26293380', 'type': 'RESULT', 'citation': 'Goede V, Busch R, Bahlo J, Chataline V, Kremers S, Muller L, Reschke D, Schlag R, Schmidt B, Vehling-Kaiser U, Wedding U, Stilgenbauer S, Hallek M. Low-dose fludarabine with or without darbepoetin alfa in patients with chronic lymphocytic leukemia and comorbidity: primary results of the CLL9 trial of the German CLL Study Group. Leuk Lymphoma. 2016;57(3):596-603. doi: 10.3109/10428194.2015.1079314. Epub 2015 Oct 12.'}, {'pmid': '26377031', 'type': 'RESULT', 'citation': 'Goede V, Bahlo J, Chataline V, Eichhorst B, Durig J, Stilgenbauer S, Kolb G, Honecker F, Wedding U, Hallek M. Evaluation of geriatric assessment in patients with chronic lymphocytic leukemia: Results of the CLL9 trial of the German CLL study group. Leuk Lymphoma. 2016;57(4):789-96. doi: 10.3109/10428194.2015.1091933. Epub 2015 Oct 13.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Darbepoetin alfa may cause the body to make more red blood cells. It is not yet known whether fludarabine is more effective with or without darbepoetin alfa in treating chronic lymphocytic leukemia.\n\nPURPOSE: This phase III trial is studying fludarabine to see how well it works when given together with or without darbepoetin alfa in treating older patients with chronic lymphocytic leukemia.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the efficacy of fludarabine with or without darbepoetin alfa in geriatric patients with chronic lymphocytic leukemia and relevant comorbidities.\n* Determine the effect of these regimens in reducing anemia, lowering the requirements of transfusion, and reducing the duration and frequency of hospitalization in these patients.\n* Determine the quality of life of patients treated with these regimens.\n* Determine event-free, progression-free, and overall survival of patients treated with these regimens.\n* Evaluate the medical-economical aspects of these regimens in these patients\n\nOUTLINE: This is a multicenter study. Patients are stratified according to hemoglobin value (\\< 12 g/dL \\[stratum 1\\] vs \\> 12 g/dL \\[stratum 2\\]). Patients are assigned to 1 of 2 treatment strata.\n\n* Stratum 1: Patients receive fludarabine IV on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses. Patients also receive darbepoetin alfa subcutaneously once weekly for up to 6 weeks.\n* Stratum 2: Patients receive fludarabine as in stratum 1. Quality of life is evaluated periodically.\n\nPROJECTED ACCRUAL: A total of 348 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Diagnosis of chronic lymphocytic leukemia (CLL) meeting 1 of the following criteria:\n\n * Previously untreated disease\n * Progressive or relapsed CLL after treatment with nonpurine analog-containing regimens as chlorambucil or bendamustine hydrochloride\n* Meets 1 of the following staging criteria:\n\n * Binet stage A disease with B symptoms requiring treatment\n * Binet stage B disease requiring treatment, meeting ≥ 1 of the following criteria:\n\n * Rapid disease progression\n * Enlarged lymph nodes and organs\n * Severe B symptoms\n * Binet stage C disease\n* Must have comorbidities (i.e., CIRS score \\> 6)\n* Must have restricted kidney function (i.e., creatinine clearance \\< 70mL/min)\n* No transformation to aggressive non-Hodgkin's lymphoma (Richter's syndrome)\n\nPATIENT CHARACTERISTICS:\n\n* Life expectancy \\> 6 months\n* Creatinine clearance \\> 30 mL/min\n* No active second malignancy\n* No active bacterial, viral, or fungal infection\n* No conditions that would preclude substitution of iron\n* No severe myocardial, coronary, or respiratory insufficiency\n* No severe liver insufficiency\n* No known hypersensitivity to darbepoetin alfa\n* No cerebral dysfunction that would preclude participation in the required study procedures\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No concurrent participation in another clinical trial"}, 'identificationModule': {'nctId': 'NCT00281892', 'briefTitle': 'Fludarabine and Darbepoetin Alfa in Treating Older Patients With Chronic Lymphocytic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'German CLL Study Group'}, 'officialTitle': 'Darbepoetin Alfa in Patients With Chronic Lymphocytic Leukemia and Comorbidity', 'orgStudyIdInfo': {'id': 'CLL9'}, 'secondaryIdInfos': [{'id': 'GCLLSG-CLL9'}, {'id': 'EU-20561'}, {'id': 'AMGEN-GCLLSG-CLL9'}, {'id': '2005-003014-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fludarabine plus Darbopoetin', 'description': 'Group 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles and 500 mcg of darbepoetin alfa subcutaneously every 3 weeks', 'interventionNames': ['Biological: Fludarabine plus Darbopoetin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fludarabine mono', 'description': 'Group 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles with no additional growth factor support.\n\nGroup 2 - Patients with an initial Hb-value more than 12 g/dl start to receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles . Patients of group 2 will be eventually randomized at later timepoints, if the Hb-value drops below 12 g/dl. Randomized patients will receive either 500 mcg darbepoetin alfa subcutaneously every 3 weeks or continue therapy with fludarabine without additional administration of darbepoetin alfa.', 'interventionNames': ['Drug: Fludarabine mono']}], 'interventions': [{'name': 'Fludarabine plus Darbopoetin', 'type': 'BIOLOGICAL', 'description': 'Group 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles and 500 mcg of darbepoetin alfa subcutaneously every 3 weeks', 'armGroupLabels': ['Fludarabine plus Darbopoetin']}, {'name': 'Fludarabine mono', 'type': 'DRUG', 'description': 'Group 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles with no additional growth factor support.\n\nGroup 2 - Patients with an initial Hb-value more than 12 g/dl start to receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles . Patients of group 2 will be eventually randomized at later timepoints, if the Hb-value drops below 12 g/dl. Randomized patients will receive either 500 mcg darbepoetin alfa subcutaneously every 3 weeks or continue therapy with fludarabine without additional administration of darbepoetin alfa.', 'armGroupLabels': ['fludarabine mono']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86150', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '65812', 'city': 'Bad Soden', 'country': 'Germany', 'facility': 'Onkologische Schwerpunktpraxis und Tagesklinik Dres', 'geoPoint': {'lat': 50.28857, 'lon': 9.36404}}, {'zip': '13347', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Internistische Gemeinschaftspraxis - Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite - Campus Charite Mitte', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Augusta-Kranken-Anstalt gGmbH', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': 'D-50924', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Medizinische Universitaetsklinik I at the University of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '40211', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Internistische Praxis - Dusseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': 'D-26721', 'city': 'Emden', 'country': 'Germany', 'facility': 'Hans - Susemihl - Krankenhaus', 'geoPoint': {'lat': 53.36592, 'lon': 7.20846}}, {'zip': 'D-45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': 'D-15236', 'city': 'Frankfurt (Oder)', 'country': 'Germany', 'facility': 'Klinikum Frankfurt (Oder) GmbH', 'geoPoint': {'lat': 52.34714, 'lon': 14.55062}}, {'zip': '70839', 'city': 'Gerlingen', 'country': 'Germany', 'facility': 'Internistische Praxis - Gerlingen', 'geoPoint': {'lat': 48.79954, 'lon': 9.06316}}, {'zip': '82110', 'city': 'Germering', 'country': 'Germany', 'facility': 'Internistische Praxisgemeinschaft', 'geoPoint': {'lat': 48.13392, 'lon': 11.3765}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '06110', 'city': 'Halle', 'country': 'Germany', 'facility': 'Internistische Gemeinschaftspraxis - Halle', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': 'D-20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Medical Center Hamburg - Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': 'D-55743', 'city': 'Idar-Oberstein', 'country': 'Germany', 'facility': 'Clinic for Bone Marrow Transplantation and Hematology and Oncology', 'geoPoint': {'lat': 49.71443, 'lon': 7.30776}}, {'zip': 'D-67653', 'city': 'Kaiserslautern', 'country': 'Germany', 'facility': 'Westpfalz-Klinikum GmbH', 'geoPoint': {'lat': 49.443, 'lon': 7.77161}}, {'zip': '76133', 'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'Staedtisches Klinikum Karlsruhe gGmbH', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': 'D-87439', 'city': 'Kempten', 'country': 'Germany', 'facility': 'Klinikum Kempten Oberallgaeu', 'geoPoint': {'lat': 49.96729, 'lon': 7.93702}}, {'zip': '96317', 'city': 'Kronach', 'country': 'Germany', 'facility': 'Internistische Onkologische Praxis - Kronach', 'geoPoint': {'lat': 50.23963, 'lon': 11.33308}}, {'zip': '84028', 'city': 'Landshut', 'country': 'Germany', 'facility': 'Internistische Praxis - Landshut', 'geoPoint': {'lat': 48.52961, 'lon': 12.16179}}, {'zip': '66822', 'city': 'Lebach', 'country': 'Germany', 'facility': 'Caritas - Krakenhaus Lebach', 'geoPoint': {'lat': 49.41122, 'lon': 6.90988}}, {'zip': 'D-26789', 'city': 'Leer', 'country': 'Germany', 'facility': 'Onkologische Schwerpunktpraxis - Leer', 'geoPoint': {'lat': 53.23157, 'lon': 7.461}}, {'zip': 'D-39130', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Staedtisches Klinikum Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': 'D-41063', 'city': 'Mönchengladbach', 'country': 'Germany', 'facility': 'Hospital Maria-Hilf II', 'geoPoint': {'lat': 51.18539, 'lon': 6.44172}}, {'zip': 'D-80335', 'city': 'Munich', 'country': 'Germany', 'facility': 'Munich Oncologic Practice at Elisenhof', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': 'D-81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': 'D-81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'Klinikum der Universitaet Muenchen - Grosshadern Campus', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': 'D-81679', 'city': 'Munich', 'country': 'Germany', 'facility': 'Haematologische Schwerpunktpraxis', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': 'D-73557', 'city': 'Mutlangen', 'country': 'Germany', 'facility': 'Klinikum Schwaebisch Gmuend Stauferklinik', 'geoPoint': {'lat': 48.82588, 'lon': 9.79714}}, {'zip': '81245', 'city': 'München', 'country': 'Germany', 'facility': 'Hamatologie/Onkologie Praxisgemeinschaft - Muenchen', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': 'D-81241', 'city': 'München', 'country': 'Germany', 'facility': 'Haematologische-onkologische GemeinschaftspraxisSchick - Schick - Schmidt - Wiesmeier', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': 'D-66538', 'city': 'Neunkirchen', 'country': 'Germany', 'facility': 'Onkologische Schwerpunktpraxis Dr. Schmidt', 'geoPoint': {'lat': 49.34449, 'lon': 7.18045}}, {'zip': '22844', 'city': 'Norderstedt', 'country': 'Germany', 'facility': 'Praxis fuer Haematologie und Interne Onkologie', 'geoPoint': {'lat': 53.70177, 'lon': 9.99328}}, {'zip': 'D-26121', 'city': 'Oldenburg', 'country': 'Germany', 'facility': 'Internistische Gemeinschaftspraxis - Oldenburg', 'geoPoint': {'lat': 53.14039, 'lon': 8.21479}}, {'zip': '75179', 'city': 'Pforzheim', 'country': 'Germany', 'geoPoint': {'lat': 48.88436, 'lon': 8.69892}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Scherpunktpraxis fur Hematologie und Onkologie', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': 'D-93049', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Krankenhaus Barmherzige Brueder Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '66113', 'city': 'Saarbrücken', 'country': 'Germany', 'facility': 'Schwerpunktpraxis fuer Haematologie und Onkologie', 'geoPoint': {'lat': 49.23262, 'lon': 7.00982}}, {'zip': 'D-57072', 'city': 'Siegen', 'country': 'Germany', 'facility': 'St. Marien - Krankenhaus Siegen GMBH', 'geoPoint': {'lat': 50.87481, 'lon': 8.02431}}, {'zip': 'D-72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Southwest German Cancer Center at Eberhard-Karls-University', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': 'D-89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': 'D-49377', 'city': 'Vechta', 'country': 'Germany', 'facility': 'St. Marienhospital - Vechta', 'geoPoint': {'lat': 52.72632, 'lon': 8.28598}}, {'zip': 'D-92637', 'city': 'Weiden', 'country': 'Germany', 'facility': 'Haematologische Praxis', 'geoPoint': {'lat': 49.67682, 'lon': 12.15613}}, {'zip': 'D-42283', 'city': 'Wuppertal', 'country': 'Germany', 'facility': 'Helios Kliniken Wuppertal University Hospital', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}, {'zip': '97070', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Hamatologisch - Onkologische Praxis Wurzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'Michael Hallek, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medizinische Universitaetsklinik I at the University of Cologne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German CLL Study Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}