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ISRCTN
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ISRCTN31378214
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ClinicalTrials.gov identifier
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Public title
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Prognostic factors and early risk-adapted therapy in patients with chronic lymphocytic leukemia in Binet stage A
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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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CLL1
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Study hypothesis
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1. Identification of a group of high risk patients in Binet stage A
2. Evaluation of the efficacy of an early risk-adapted therapy in Binet stage A 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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Chronic Lymphocytic Leukemia (CLL) Binet stage A, untreated
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Participants - inclusion criteria
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1. Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) in Binet stage A
2. Initial diagnosis within the last three years
3. No previous therapy
4. Age between 18 and 75 years
5. Eastern Cooperative Oncology Group (ECOG) status zero to two
6. Signed informed consent
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Participants - exclusion criteria
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1. Autoimmune cytopenia
2. Severe concommitant disease
3. Concomitant secondary neoplasia
4. Participation in another clinical trial
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Anticipated start date
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01/07/1997
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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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320
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Interventions
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1. Intervention: randomised treatment with fludarabine (25 mg/m^2, days one to five, every 28 days, for a maximum of six courses) in high risk patients
2. Control: Watch and wait
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Primary outcome measure(s)
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Progression-free survival
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Secondary outcome measure(s)
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1. Overall survival
2. Quality of life
3. Incidence of infections
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Sources of funding
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1. German Cancer Aid (Deutsche Krebshilfe), Bonn (Germany)
2. German Chronic Lymphocytic Leukemia Study Group (GCLLSG), Cologne (Germany)
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Trial website
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Publications
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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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Sponsor
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German CLL Study Group (GCLLSG) (Germany)
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Address
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Department of Internal Medicine I
University of Cologne
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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 4783988
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Email
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cll-studie@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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31/08/2005
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Last edited
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06/11/2009
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Date ISRCTN assigned
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06/10/2005
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