Leukaemia (chronic) Cancer Chronic lymphomatic leukaemia
Conditions
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:
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death and death related to CLL, response to treatment, toxicity and compliance | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed