Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MRC CML 2000 (IVa)
Study information
Scientific title
Medical Research Council/ European Blood and Marrow Transplant Prospective Randomised Trial of Autograft in Chronic Myeloid Leukaemia (CML)
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
Two Arms:
1. Control: Interferon (IFN) Starting dose 3 x 10(6) units x 3/week escalating to 5 x 10(6) units/m(2) daily. Adjusted to maintain leukocyte count 2-4 x 10(9)/l. Use of hydroxyurea and/or ara-c optional.
2. Investigational: Mobilised or straight autograft, followed by IFN (+/- Ara-c).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/10/1996
Overall trial end date
30/10/2001
Reason abandoned (if study stopped)
Participant recruitment issue
Eligibility
Participant inclusion criteria
1. Newly diagnosed Ph-positive and/or breakpoint cluster region (BCR)-abelson (ABL) positive CML
2. Aged 15-65
3 .Chronic phase disease
4. No contraindication to the collection of peripheral blood progenitor cells before commencing treatment
5. No major organ impairment
6. No pregnancy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration.
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/10/1996
Recruitment end date
30/10/2001
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
Not defined
Funder name
European Bone Marrow Transplantation Group
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
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