Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00002869
Protocol/serial number
G8223452
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Leukaemia
Intervention
High/low-dose Interferon (IFN).
Optional use of arm-C in addition to randomised IFN therapy.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/1995
Overall trial end date
01/01/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
800
Participant exclusion criteria
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
Recruitment start date
01/04/1995
Recruitment end date
01/01/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Haematology
Edinburgh
EH4 2XU
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 270000
research.services@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2004 results on http://www.ncbi.nlm.nih.gov/pubmed/15010373
Publication citations
-
Results
Kluin-Nelemans HC, Buck G, le Cessie S, Richards S, Beverloo HB, Falkenburg JH, Littlewood T, Muus P, Bareford D, van der Lelie H, Green AR, Roozendaal KJ, Milne AE, Chapman CS, Shepherd P, , Randomized comparison of low-dose versus high-dose interferon-alfa in chronic myeloid leukemia: prospective collaboration of 3 joint trials by the MRC and HOVON groups., Blood, 2004, 103, 12, 4408-4415, doi: 10.1182/blood-2003-10-3605.