Third Medical Research Council Trial in Chronic Lymphomatic Leukaemia
ISRCTN | ISRCTN23736115 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN23736115 |
Secondary identifying numbers | G8223452 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 24/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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
Contact information
Prof D Catovsky
Scientific
Scientific
Royal Marsden Hospital
Fulham Road
London
SW3 6JJ
United Kingdom
Phone | +44 (0)20 7352 8171 |
---|---|
abc@email.com |
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/1990 |
Completion date | 01/04/1995 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Marsden Hospital
London
SW3 6JJ
United Kingdom
SW3 6JJ
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
Phone | +44 (0)20 7636 5422 |
---|---|
clinical.trial@headoffice.mrc.ac.uk | |
Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
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 |
Editorial Notes
24/10/2019: No publications found. All search options exhausted.