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ISRCTN
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ISRCTN36294212
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ClinicalTrials.gov identifier
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NCT00262795
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Public title
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Treatment of elderly patients with advanced chronic lymphocytic leukemia (CLL) with fludarabine versus chlorambucil
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Scientific title
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Acronym
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N/A
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Serial number at source
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CLL5 protocol
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Study hypothesis
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Superiority of fludarabine compared to chlorambucil in elderly patients
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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B-Chronic Lymphocytic Leukemia (CLL)
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Participants - inclusion criteria
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1. B-CLL
2. Binet stage C or Binet stage B with symptoms, which require therapy, or Binet stage A with severe B-symptoms
3. Age 66 - 79 years
4. No previous treatment
5. Signed informed-consent
6. Life expectancy of more than six months
7. Eastern Cooperative Oncology Group (ECOG) status zero, one or two
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Participants - exclusion criteria
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1. Severe organ dysfunction
2. Concomitant or previous neoplasm
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Anticipated start date
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01/07/1999
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Anticipated end date
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30/09/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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200
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Interventions
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Fludarabine 25 mg/m^2 for five days intravenously, q 28 days, maximum of six courses.
Chlorambucil 0.4 mg/kg bodyweight with increasing of the dose up to 0.8 mg/kg bodyweight, q 15 days, maximum 12 months.
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Primary outcome measure(s)
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Progression free survival, overall survival, duration of remission, quality of remission.
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Secondary outcome measure(s)
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1. Toxicity
2. Quality of life
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Sources of funding
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1. German Cancer Aid (Deutsche Krebshilfe) (Germany)
2. Medac Schering Onkologie GmBH (Germany)
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Trial website
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http://www.dcllsg.de/en/cll5/index.php
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19605849
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Contact name
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Prof
Michael
Hallek
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Address
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Kerpenerstr. 62
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City/town
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Cologne
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Zip/Postcode
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50924
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Country
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Germany
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Tel
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+49 221 4784400
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Email
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michael.hallek@uk-koeln.de
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Sponsor
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German CLL Study Group (GCLLSG)
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Address
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Herderstr. 52-54
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City/town
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Cologne
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Zip/Postcode
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50931
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Country
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Germany
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Tel
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+49 221 4783988
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Email
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cllstudie@uk-koeln.de
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Sponsor website:
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http://www.dcllsg.de
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Date applied
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30/06/2005
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Last edited
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16/09/2009
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Date ISRCTN assigned
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11/10/2005
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