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ISRCTN
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ISRCTN61147621
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DOI
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10.1186/ISRCTN61147621
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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CML IV - Chronic phase chronic myeloid leukaemia/CML 2000
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Scientific title
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Acronym
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CML 2000
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Serial number at source
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G8223452
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Study hypothesis
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To improve on the best current therapy in chronic phase CML for patients who do not undergo allogeneic BMT with respect to prolonging survival. The trial will compare the combination of a cycle of chemotherapy and an autograft with subsequent alpha IFN with alpha IFN therapy alone. Also, to compare whether low dose alpha IFN therapy is as effective as high dose alpha IFN therapy.
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Lay summary
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Not provided at time of registration
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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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United Kingdom
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Disease/condition/study domain
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Leukaemia
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Participants - inclusion criteria
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1. The interval from diagnosis to registration does not exceed 3 months (if received only hydroxyurea in these 3 months proceed to register, if alpha Interferon (IFN) has been given contact co-ordinators)
2. They are aged 18-60; they have newly diagnosed CML
3. They have acceptable criteria for chronic phase
4. They have given informed consent and are willing to be randomised, there is no contraindication to collection of blood or marrow progenitor cells before treatment is commenced
5. They are not pregnant
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/1996
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Anticipated end date
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31/10/2001
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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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800
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Interventions
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Cycle of chemotherapy and an autograft with subsequent IFN/IFN therapy alone
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Primary outcome measure(s)
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Length of survival, quality of life, cytogenetic response
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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Contact name
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Prof
I
Franklin
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Address
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Academic Transfusion Medicine Unit, Cancer Division
Section of Experimental Haematology
Glasgow Royal Infirmary
10 Alexandra Parade
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City/town
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Glasgow
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Zip/Postcode
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G31 2ER
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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25/10/2000
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Last edited
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15/08/2012
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Date ISRCTN assigned
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25/10/2000
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