Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CML IIIB
Study information
Scientific title
Trial of alpha-interferon in chronic myeloid leukaemia and a comparison of busulphan and hydroxyurea for induction and maintenance
Acronym
Study hypothesis
Not provided at time of registration.
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 (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
Phase
Not Specified
Drug names
Alpha-Interferon , busulphan , hydroxyurea
Primary outcome measure
Not provided at time of registration.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/08/2000
Overall trial end date
01/08/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
Not provided at time of registration.
Total final enrolment
587
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/08/2000
Recruitment end date
01/08/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Government
Funder name
UK Medical Research Council
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
1995 results in: https://www.ncbi.nlm.nih.gov/pubmed/7760609 (added 15/11/2019)