| Source of record | UK Trials |
| ISRCTN | ISRCTN23736115 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | G8223452 |
| Public title | Third Medical Research Council Trial in Chronic Lymphomatic Leukaemia |
| Scientific title |
|
| Acronym | MRC CLL3 |
| Disease/condition/study domain | Leukaemia (chronic) |
| 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. |
| Design/methodology | Randomised controlled trial. |
| Research ethics review | Not provided at time of registration
|
| Countries of trial | United Kingdom
|
| Participants - 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 |
| Participants - 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. |
| Patient information material |
|
| Anticipated start date | 01/04/1990 |
| Anticipated end date | 01/04/1995 |
| Status of trial | Completed |
| Target number of participants | 350 |
| Interventions | 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. |
| Primary outcome measure(s) | Death and death related to CLL, response to treatment, toxicity and compliance |
| Secondary outcome measure(s) | Not provided at time of registration
|
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.uk |
| Contact name | Prof D Catovsky |
| Contact details | Royal Marsden Hospital
Fulham Road
London
United Kingdom
SW3 6JJ |
| Contact telephone | +44 (0)20 7352 8171 |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN23736115 |
| Date last extracted from ISRCTN register | 17/04/2008 |
