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ISRCTN
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ISRCTN31486124
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ClinicalTrials.gov identifier
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Public title
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Treatment of advanced, relapsed chronic lymphocytic leukemia (CLL) with fludarabine, miroxantrone and cyclophosphamide combination therapy with or without granulocyte colony stimulating factor (G-CSF)
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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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CLL6 protocol
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Study hypothesis
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The prophylactic administration of G-CSF prevents the incidence of infections during relapse chemotherapy in chronic lymphocytic leukemia (CLL) 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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Relapsed B-cell chronic lymphocytic leukemia (B-CLL)
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Participants - inclusion criteria
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1. B-cell chronic lymphocytic leukemia (B-CLL)
2. Binet stage C, Binet stage B with treatment indication
3. Maximum of 3 previous treatment regimen
4. Age 18-70 years
5. Life expectancy more than 6 months
6. Eastern Cooperative Oncology Group (ECOG) 0-3
7. Normal cardiac function
8. Signed inform consent
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Participants - exclusion criteria
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1. Severe organ dysfunction
2. Autoimmune haemolytic anaemia (AIHA)
3. More than 3 chemotherapy regimens
4. Concomitant or previous neoplasm
5. Non-response to previous treatment with Fludarabine + Cyclophosphamide, Fludarabine + Mitoxantrone, Fludarabine + Epirubicine
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Anticipated start date
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06/08/1999
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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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165
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Interventions
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Fludarabine 25 mg/m^2 day 1-3, mitoxantrone 8 mg/m^2 day 1, cyclophosphamide 200 mg/m^2 day 1-3, repeated every 28 days, maximum 6 courses.
Arm A with G-CSF: 5 µg/kg bodyweight/day subcutaneously (sc) beginning on day +6 until neutrophil recovery above 1500/µl.
Arm B without G-CSF.
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Primary outcome measure(s)
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1. Incidence of severe and life threatening infections
2. Incidence of severe side effects
3. Remission rate
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Secondary outcome measure(s)
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1. Overall survival
2. Progression free survival
3. Quality of remission
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Sources of funding
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Amgen (USA)
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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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Tel
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+49 221 478 4400
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Fax
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+49 221 478 86886
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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) (Germany)
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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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+49 221 478 3988
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Fax
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+49 221 478 86886
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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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09/11/2009
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Date ISRCTN assigned
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11/10/2005
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