Chronic Lymphocytic Leukaemia (CLL) Cancer Leukaemia
Conditions
Interventions
All patients will receive fludarabine with cyclophosphamide plus mitoxantrone (FCM) and half will be randomised to receive simultaneous rituximab (FCM-R)
Sponsors
Leeds Acute NHS Trust (UK)
Eligibility
Inclusion criteria
Inclusion criteria: CLL requiring therapy, had previous treatment with at least one chemotherapeutic regimen, be capable of giving written informed consent, World Health Organisation (WHO) 0, 1 or 2, life expectancy of at least 12 weeks.
Exclusion criteria
Exclusion criteria: Previous treatment with F (or other purine analogues) combined with C and M, previous treatment with R, past history of anaphylaxis following exposure to rat or mouse derived complementarity determining region grafted humanized monoclonal antibodies, toxicity attributable to purine analogues, active infection, other severe, concurrent diseases or mental disorders that could interfere with their ability to participate in the study, patients with a creatinine clearance of less than 30 ml/min (measured or derived by the Cockcroft formula), pregnant or unwilling to use adequate contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not provided at time of registration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration. | — |
Countries
United Kingdom
Outcome results
None listed