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ISRCTN
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ISRCTN68784584
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DOI
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10.1186/ISRCTN68784584
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ClinicalTrials.gov identifier
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NCT00002869
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EudraCT number
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Public title
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CML V - chronic phase Chronic Myeloid Leukaemia
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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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G8223452
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Study hypothesis
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To determine whether there is any significant difference between the duration of chronic phase and overall survival in patients given low-dose alpha IFN, to study toxicity profiles in the two arms of the trial as assessed by WHO criteria and by percentage of patients requiring dose reduction or abandoning therapy because of side effects, to study haematologic and cytogenetic response at six monthly intervals on treatment with either low-dose or high-dose alpha IFN.
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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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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. Newly diagnosed, previously untreated CML in chronic phase (therapeutic or back up leucapheresis does not preclude entry to the trial. Patients may be started on hydroxyurea for up to 4 weeks before randomisation)
2. The presence of the Ph chromosome or molecular evidence of Breakpoint Cluster Region (BCR)/Abelson (ABL) re-arrangement
3. World Health Organisation (WHO) performance status is 0./1, or 2 4. There is informed consent in accordance with MRC requirements and that of local ethics committees
5. Adequate hepatic and renal functions defined by bilirubin and creatinine levels below twice the upper limit. The possibility of allogeneic Bone Marrow Transplant (BMT) does not preclude entry to the trial
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Participants - exclusion criteria
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1. Received previous treatment for CML
2. WHO performance status 3 or 4
3. Accelerated phase or established blast crisis; severe concurrent hepatic, renal or cardio-vascular problems or a history of severe depression in the past
4. Pregnancy
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Anticipated start date
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01/04/1995
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Anticipated end date
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01/01/2002
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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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High/low-dose Interferon (IFN).
Optional use of arm-C in addition to randomised IFN therapy.
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Primary outcome measure(s)
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1. Overall survival
2. Frequency of haematologic and cytogenetic response
3. Duration of chronic phase and overall survival
4. Toxicity profiles
5. Side effects
6. Performance status
7. Quality of life
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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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2004 results on http://www.ncbi.nlm.nih.gov/pubmed/15010373
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Contact name
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Dr
P
Shepherd
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Address
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Department of Haematology
Western General Hospital
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City/town
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Edinburgh
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Zip/Postcode
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EH4 2XU
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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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University of Oxford (UK)
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Address
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University Offices
Wellington Square
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City/town
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Oxford
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Zip/Postcode
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OX1 2JD
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Country
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United Kingdom
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Tel
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+44 (0)1865 270000
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Email
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research.services@admin.ox.ac.uk
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Sponsor website:
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http://www.ox.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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07/08/2009
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Date ISRCTN assigned
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25/10/2000
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