Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G8223452
Study information
Scientific title
Acronym
MRC CLL3
Study hypothesis
To establish whether the addition of epirubicin to standard chlorambucil therapy prolongs the duration of remission and survival, to evaluate the therapeutic benefit of anthracyclines in CLL by comparing the objective response rate to chlorambucil alone with that to chlorambucil + epirubicin, to assess the relative toxicities of two regimens.
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
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Leukaemia (chronic)
Intervention
Following randomisation stage C patients only receive pre-treatment with prednisolone. Patients are then treated on one of two treatment regimens depending upon the initial randomisation:
1. Regimen A: Chlorambucil orally daily for 6 days. Cycle repeated every 28 days.
2. Regimen B: Epirubicin on day 1 followed by chlorambucil orally for 6 days. Cycle to be repeated every 28 days.
Intervention type
Drug
Phase
Not Specified
Drug names
anthracyclines
Primary outcome measure
Death and death related to CLL, response to treatment, toxicity and compliance
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/1990
Overall trial end date
01/04/1995
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All patients with B-cell chronic lymphoblastic leukaemia diagnosed by a persistent blood lymphocytosis (greater than 10 x 10^9/l) and bone marrow infiltration of at least 40% who require treatment
2. Previously untreated stage B and C disease
3. Stage A patients showing evidence of disease progression
4. Previously treated patients who:
4.1 Have not received an anthracycline or anthracenedione
4.2 Are not considered to be resistant to chlorambucil
4.3 Have relapsed off therapy and need further treatment because of disease progression
5. No concomitant treatment with any other cytotoxic or immunomodulatory therapy
6. No other life threatening disease
7. No medical contraindications to treatment protocols
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
350
Participant exclusion criteria
Patients who have another life threatening disease; they are not expected to complete the study treatment for other reasons; they are having concomitant treatment with any cytotoxic or immunomodulatory therapy; there is evidence of heart disease which would preclude treatment with anthracycline or they have not given informed consent.
Recruitment start date
01/04/1990
Recruitment end date
01/04/1995
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Marsden Hospital
London
SW3 6JJ
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
Research council
Funder name
Medical Research Council (MRC) (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