Trial of alpha-interferon in chronic myeloid leukaemia and a comparison of busulphan and hydroxyurea for induction and maintenance

ISRCTN	ISRCTN46123985
DOI	https://doi.org/10.1186/ISRCTN46123985
Secondary identifying numbers	CML IIIB

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
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	Trial of alpha-interferon in chronic myeloid leukaemia and a comparison of busulphan and hydroxyurea for induction and maintenance
Study objectives	Not provided at time of registration.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Leukaemia (chronic)
Intervention	There are four treatment arms, clinicians may choose to randomise between only arms 1 and 2, 3 and 4, 2 and 4 or to randomise between all treatment arms. 1. Regimen A: Induction therapy with busulphan followed by maintenance therapy with busulphan plus alpha-interferon. 2. Regimen B: Induction therapy with busulphan followed by maintenance therapy with busulphan only. 3. Regimen C: Induction therapy with hydroxyurea followed by maintenance therapy with hydroxyurea plus alpha-interferon. 4. Regimen D: Induction therapy with hydroxyurea followed by maintenance therapy with hydroxyurea only.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Alpha-Interferon , busulphan , hydroxyurea
Primary outcome measure	Not provided at time of registration.
Secondary outcome measures	Not provided at time of registration.
Overall study start date	01/08/2000
Completion date	01/08/2005

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Target number of participants	Not provided at time of registration.
Total final enrolment	587
Key inclusion criteria	1. Aged over 75 years with either Ph positive or Ph negative chronic myeloid leukaemia in chronic phase. Patients over 75 years or patients unwilling to accept alpha-interferon, may be randomised to busulphan or hydroxyurea, but not interferon or no interferon 2. Adequate renal function 3. No severe concurrent hepatic, renal, cardiovascular, organic brain disease or psychiatric illness 4. Patients with established blast cell crisis or extramedullary granulocytic sarcomas are to be excluded 5. Patients with accelerated phase or platelet count below that specified in the protocol are not eligible
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/08/2000
Date of final enrolment	01/08/2005

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Government

UK Medical Research Council

No information available

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	03/06/1995	15/11/2019	Yes	No

15/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.