Third Medical Research Council Trial in Chronic Lymphomatic Leukaemia

ISRCTN	ISRCTN23736115
DOI	https://doi.org/10.1186/ISRCTN23736115
Protocol serial number	G8223452
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof D Catovsky
Scientific

Royal Marsden Hospital
Fulham Road
London
SW3 6JJ
United Kingdom

Phone	+44 (0)20 7352 8171
Email	abc@email.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Third Medical Research Council Trial in Chronic Lymphomatic Leukaemia
Study acronym	MRC CLL3
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	anthracyclines
Primary outcome measure(s)	Death and death related to CLL, response to treatment, toxicity and compliance
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/04/1995

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	350
Key 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
Key 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.
Date of first enrolment	01/04/1990
Date of final enrolment	01/04/1995

Royal Marsden Hospital

London
SW3 6JJ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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