CML V - chronic phase Chronic Myeloid Leukaemia

ISRCTN	ISRCTN68784584
DOI	https://doi.org/10.1186/ISRCTN68784584
ClinicalTrials.gov number	NCT00002869
Secondary identifying numbers	G8223452

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr P Shepherd
Scientific

Department of Haematology
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Leukaemia
Intervention	High/low-dose Interferon (IFN). Optional use of arm-C in addition to randomised IFN therapy.
Intervention type	Other
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 study start date	01/04/1995
Completion date	01/01/2002

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	800
Key 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
Key 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
Date of first enrolment	01/04/1995
Date of final enrolment	01/01/2002

Department of Haematology

Edinburgh
EH4 2XU
United Kingdom

University of Oxford (UK)
University/education

University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom

Phone	+44 (0)1865 270000
Email	research.services@admin.ox.ac.uk
Website	http://www.ox.ac.uk/
"ROR"	https://ror.org/052gg0110

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/06/2004		Yes	No