Chronic lymphocytic leukaemia (CLL) Cancer Lymphoid leukaemia
Conditions
Interventions
This trial aims to recruit 218 patients over 18 months. Patients will be randomised to receive six cycles of either FCR or FCM-R. Cycles of FCR and FCM-R are reported every 28 days for a total of six
Sponsors
Leeds Teaching Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, at least 18 years old 2. B-cell chronic lymphocytic leukaemia (B-CLL) with a characteristic immunophenotype 3. Binet's Stages B, C or Progressive A 4. Requirement for therapy as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria (must meet one of the following criteria: evidence of progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia) 5. Massive (i.e. 6 cm below the left costal margin) or progressive or symptomatic splenomegaly 6. Massive nodes (i.e. 10 cm in longest diameter) or progressive or sypmtomatic lymphodenopathy 7. Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time (LDT) of less than 6 months as long as the lymphocyte count is over 30 x 10^9/L 8. A minimum of any one of the following disease-related symptoms must be present: 8.1. Unitentional weight loss more than or equal to 10% within the previous 6 months 8.2. Significant fatigue (i.e. Eastern Cooperative Oncology Group performance status 2 or worse; cannot work or unable to perform usual activities) 8.4. Fevers of greater than 38°C for two or more weeks without other evidence of infection 8.5. Night sweats for more than one month without evidence of infection 9. No prior therapy for CLL 10. Able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Prior therapy for CLL 2. Active infection 3. Past history of anaphylaxis following exposure to rat or mouse derived complementarity-determining regions (CDR)-grafted humanised monoclonal antibodies 4. Pregnancy, lactation or women of child bearing potential unwilling to use medically approved contraception whilst receiving treatment 5. Men whose partners are capable of having children but who are not willing to use appropriate medically approved contraception during the study, unless they are surgically sterile 6. Central nervous system (CNS) involvement with CLL 7. Mantle cell lymphoma 8. Other severe, concurrent disease or mental disorders 9. Known human immunodeficiency virus (HIV) positive 10. Patient has active or prior hepatitis B or C 11. Active secondary malignancy excluding basal cell lymphoma 12. Persisting severe pancytopenia (neutrophils less than 0.5 x 10^9/L or platelets less than 50 x 10^9/L), trasfusion dependent anaemia and active haemolysis 13. Patients with a creatinine clearance of less than 30 ml/min (either measured or derived by the Cockroft formula)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving a complete response (CR) at three months post end-of-treatment as specified by the IWCLL criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients with undetectable minimal residual disease, measured at three months post-end-of-treatment 2. Overall response rate defined as complete or partial remission by the IWCLL criteria, measured at three months post-end-of-treatment 3. Progression free survival at two years 4. Overall survival at two years 5. Safety and toxicity, measured at two years after randomisation | — |
Countries
England, Ireland, United Kingdom
Outcome results
None listed