Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT00004218
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2000-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'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': 'D002699', 'term': 'Chlorambucil'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'C042382', 'term': 'fludarabine phosphate'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D014750', 'term': 'Vincristine'}], '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': 'D010752', 'term': 'Phosphoramide Mustards'}, {'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': 'D011246', 'term': 'Pregnadienetriols'}, {'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': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-01', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-17', 'studyFirstSubmitDate': '2000-01-28', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage I chronic lymphocytic leukemia', 'stage II chronic lymphocytic leukemia', 'stage III chronic lymphocytic leukemia', 'B-cell chronic lymphocytic leukemia', 'stage 0 chronic lymphocytic leukemia'], 'conditions': ['Leukemia']}, 'referencesModule': {'references': [{'pmid': '22168274', 'type': 'RESULT', 'citation': 'Else M, Cocks K, Crofts S, Wade R, Richards SM, Catovsky D, Smith AG; UK National Cancer Research Institute (NCRI) Chronic Lymphocytic Leukaemia Trials Group. Quality of life in chronic lymphocytic leukemia: 5-year results from the multicenter randomized LRF CLL4 trial. Leuk Lymphoma. 2012 Jul;53(7):1289-98. doi: 10.3109/10428194.2011.649479. Epub 2012 Mar 1.'}, {'pmid': '21483000', 'type': 'RESULT', 'citation': 'Gonzalez D, Martinez P, Wade R, Hockley S, Oscier D, Matutes E, Dearden CE, Richards SM, Catovsky D, Morgan GJ. Mutational status of the TP53 gene as a predictor of response and survival in patients with chronic lymphocytic leukemia: results from the LRF CLL4 trial. J Clin Oncol. 2011 Jun 1;29(16):2223-9. doi: 10.1200/JCO.2010.32.0838. Epub 2011 Apr 11.'}, {'pmid': '21659360', 'type': 'RESULT', 'citation': 'Wade R, Di Bernardo MC, Richards S, Rossi D, Crowther-Swanepoel D, Gaidano G, Oscier DG, Catovsky D, Houlston RS. Association between single nucleotide polymorphism-genotype and outcome of patients with chronic lymphocytic leukemia in a randomized chemotherapy trial. Haematologica. 2011 Oct;96(10):1496-503. doi: 10.3324/haematol.2011.043471. Epub 2011 Jun 9.'}, {'pmid': '20511662', 'type': 'RESULT', 'citation': 'Oscier D, Wade R, Davis Z, Morilla A, Best G, Richards S, Else M, Matutes E, Catovsky D; Chronic Lymphocytic Leukaemia Working Group, UK National Cancer Research Institute. Prognostic factors identified three risk groups in the LRF CLL4 trial, independent of treatment allocation. Haematologica. 2010 Oct;95(10):1705-12. doi: 10.3324/haematol.2010.025338. Epub 2010 May 29.'}, {'pmid': '19016733', 'type': 'RESULT', 'citation': "Else M, Smith AG, Cocks K, Richards SM, Crofts S, Wade R, Catovsky D. Patients' experience of chronic lymphocytic leukaemia: baseline health-related quality of life results from the LRF CLL4 trial. Br J Haematol. 2008 Dec;143(5):690-7. doi: 10.1111/j.1365-2141.2008.07407.x. Epub 2008 Oct 18."}, {'pmid': '17658394', 'type': 'RESULT', 'citation': 'Catovsky D, Richards S, Matutes E, Oscier D, Dyer M, Bezares RF, Pettitt AR, Hamblin T, Milligan DW, Child JA, Hamilton MS, Dearden CE, Smith AG, Bosanquet AG, Davis Z, Brito-Babapulle V, Else M, Wade R, Hillmen P; UK National Cancer Research Institute (NCRI) Haematological Oncology Clinical Studies Group; NCRI Chronic Lymphocytic Leukaemia Working Group. Assessment of fludarabine plus cyclophosphamide for patients with chronic lymphocytic leukaemia (the LRF CLL4 Trial): a randomised controlled trial. Lancet. 2007 Jul 21;370(9583):230-239. doi: 10.1016/S0140-6736(07)61125-8.'}, {'type': 'RESULT', 'citation': 'Dearden CE, Wade RL, Else M, et al.: The combination of fludarabine and cyclophosphamide has a beneficial effect on the incidence of hemolytic anemia in chronic lymphocytic leukemia: results from the UK LRF CLL4 trial. [Abstract] Blood 110 (11): A-2044, 2007.'}, {'pmid': '23091097', 'type': 'DERIVED', 'citation': 'Skowronska A, Parker A, Ahmed G, Oldreive C, Davis Z, Richards S, Dyer M, Matutes E, Gonzalez D, Taylor AM, Moss P, Thomas P, Oscier D, Stankovic T. Biallelic ATM inactivation significantly reduces survival in patients treated on the United Kingdom Leukemia Research Fund Chronic Lymphocytic Leukemia 4 trial. J Clin Oncol. 2012 Dec 20;30(36):4524-32. doi: 10.1200/JCO.2011.41.0852. Epub 2012 Oct 22.'}]}, '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 regimen of chemotherapy is more effective for chronic lymphocytic leukemia.\n\nPURPOSE: This randomized phase III trial is studying chlorambucil to see how well it works compared to fludarabine and cyclophosphamide or fludarabine alone in treating patients with newly diagnosed chronic lymphocytic leukemia.', 'detailedDescription': "OBJECTIVES:\n\n* Compare the survival rate of patients with newly diagnosed chronic lymphocytic leukemia treated with chlorambucil alone vs fludarabine with or without cyclophosphamide.\n* Compare the response rate and duration of remission in patients treated with these regimens.\n* Compare the toxic effects of these regimens in these patients.\n* Compare the quality of life of patients treated with these regimens.\n* Determine the impact of the drug response information provided by the DiSC assay on response rate and survival in relapsed or nonresponding patients.\n* Assess the prognostic value of five genetic markers: trisomy 12 and deletions at 11q23, 13q14, p53, and 6q21 in patients treated with these regimens.\n\nOUTLINE: This is a randomized study. Patients enter one of three treatment arms in the first randomization. Depending on response, some patients may also participate in a second randomization to one of two treatment arms.\n\n* First randomization:\n\n * Arm I: Patients receive oral chlorambucil daily for 7 days. Treatment repeats every 4 weeks until maximum response or up to 1 year.\n * Arm II: Patients receive fludarabine IV or orally daily for 5 days. Treatment repeats every 4 weeks for 3-8 courses.\n * Arm III: Patients receive cyclophosphamide IV and fludarabine IV for 3 days or orally daily for 5 days. Treatment repeats every 4 weeks for 3-8 courses.\n\nPatients who relapse after being in remission for at least 1 year may repeat the initial therapy or may participate in a second randomization. Patients who experience progressive disease or relapse within 1 year after treatment proceed to a second randomization.\n\n* Second randomization:\n\n * Arm I: Treatment is guided by the results of the DiSC assay. Treatment may be one of the first-line treatments with fludarabine or standard CHOP chemotherapy repeated every 4 weeks (cyclophosphamide IV, doxorubicin IV, vincristine IV, and oral prednisolone on days 1-5) or any other therapy guided by the results of the DiSC assay.\n * Arm II: Treatment is physician's choice, which may include any of the options in arm I.\n\nQuality of life is assessed prior to initial therapy; at 3, 6, and 12 months; and then annually thereafter.\n\nPatients are followed annually for survival.\n\nPROJECTED ACCRUAL: A total of 750 patients will be accrued for this study within 6-7 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of B-cell chronic lymphocytic leukemia (CLL) requiring therapy and meeting the following criteria:\n\n * Previously untreated disease\n * Peripheral blood morphology, excluding other leukemia and low-grade lymphoma in leukemic phase\n * Cell markers: CD5+, CD23+, SmIg (weak), CD79b-, FMC7-\n * Persistent lymphocytosis (greater than 10,000/mm\\^3)\n * At least 40% bone marrow infiltration\n* Stage 0 or I progressive disease indicated by at least one of the following:\n\n * Persistent rise in lymphocyte count with doubling time less than 12 months\n * Downward trend in hemoglobin and/or platelet count\n * At least 50% increase in size of liver and/or spleen and/or lymph nodes\n * Appearance of lymphadenopathy, hepatomegaly, or splenomegaly\n * Constitutional symptoms caused by disease\n\n * Pyrexia\n * Night sweats\n * Weight loss OR\n* Stage II or III\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Not specified\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* See Disease Characteristics\n\nHepatic:\n\n* Bilirubin no greater than 2 times upper limit of normal (ULN)\\*\n* SGOT/SGPT no greater than 2 times ULN\\* NOTE: \\* Unless due to CLL\n\nRenal:\n\n* Creatinine clearance at least 30 mL/min\n\nOther:\n\n* No other cancer or life-threatening disease\n* Not pregnant\n* Fertile patients must use effective contraception during and for 6 months after study therapy\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* No concurrent corticosteroids (e.g., dexamethasone) as antiemetics\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00004218', 'briefTitle': 'Chemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia', 'nctIdAliases': ['NCT00222599'], 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Chronic Lymphocytic Leukemia Trial 4: A Randomized Comparison of Chlorambucil, Fludarabine and Fludarabine Plus Cyclophosphamide', 'orgStudyIdInfo': {'id': 'CDR0000067454'}, 'secondaryIdInfos': [{'id': 'LRF-CLL4'}, {'id': 'LRG-MRC-LEUK-CLL4'}, {'id': 'EU-99030'}, {'id': 'MRC-LEUK-CLL4'}, {'id': 'EUDRACT-58585610'}, {'id': 'ISRCTN58585610'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'chlorambucil', 'type': 'DRUG'}, {'name': 'cyclophosphamide', 'type': 'DRUG'}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG'}, {'name': 'fludarabine phosphate', 'type': 'DRUG'}, {'name': 'prednisolone', 'type': 'DRUG'}, {'name': 'vincristine sulfate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CP1181ACH', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Alvarez', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'University Hospital Rebro', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': 'GR-45110', 'city': 'Ioannina', 'country': 'Greece', 'facility': 'University of Ioannina', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}, {'zip': 'GR-26500', 'city': 'Rio Patras', 'country': 'Greece', 'facility': 'University of Patras Medical School'}, {'zip': '8', 'city': 'Dublin', 'country': 'Ireland', 'facility': "St. James' Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Galway', 'country': 'Ireland', 'facility': 'Galway University Hospital', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}, {'zip': '24100', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Ospedali Riuniti di Bergamo', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Canterbury Health Laboratories', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '115478', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Russian Academy of Medical Sciences Cancer Research Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': 'HP21 8AL', 'city': 'Aylesbury-Buckinghamshire', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Stoke Mandeville Hospital'}, {'zip': 'OX16 9A', 'city': 'Banbury', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Horton Hospital', 'geoPoint': {'lat': 52.0632, 'lon': -1.34222}}, {'zip': 'RG24 9NA', 'city': 'Basingstoke', 'state': 'England', 'country': 'United Kingdom', 'facility': 'North Hampshire Hospital', 'geoPoint': {'lat': 51.26249, 'lon': -1.08708}}, {'zip': 'B29 6JD', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Selly Oak Hospital at University Hospital NHS Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'B9 5SS', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Birmingham Heartlands Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'FY3 8NR', 'city': 'Blackpool', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Blackpool Victoria Hospital', 'geoPoint': 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