Chronic lymphocytic leukaemia (CLL) Cancer Lymphoid leukaemia
Conditions
Interventions
The recruitment target requires that approximately 96 patients are recruited into the trial per year over a three year period (total = 288).
Prior to randomisation a blood and bone marrow sample will
Sponsors
Leeds Teaching Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. At least 18 years old, either sex 2. Previous confirmation of B-CLL with a characteristic immunophenotype on peripheral blood flow cytometry 3. Maximum of three prior therapies received for CLL treatment 4. Between 6 and 12 months since completing most recent therapy for CLL 5. Response to most recent chemotherapy treatment for CLL with partial response (PR), near complete response (nCR) or complete response (CR) 6. No prior alemtuzumab therapy 7. Absence of clinically evident lymphadenopathy (largest lymph node less than 2 cm in minimum diameter) 8. Creatinine and bilirubin less than two times upper limit of normal 9. Peripheral B-cell count less than 5 x 10^9 l 10. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Disease progression after response to latest therapy 2. Active infection 3. Past history of anaphylaxis following exposure to rat or mouse derived complementarity determining region (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 diseases or mental disorders 9. Known human immunodeficiency virus (HIV) positive 10. Active secondary malignancy 11. Persisting severe pancytopenia (neutrophils less than 0.5 x 10^9/l or platelets less than 50 x 10^9/l) 12. Patients previously treated with allogeneic stem cell transplantation (SCT)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients with undetectable minimal residual disease (MRD), measured at the six month post-randomisation follow-up visit 2. Response as measured by National Cancer Institute (NCI)/International Workshop on CLL (IWCLL) criteria: 2.1. For patients receiving treatment with alemtuzumab: after six weeks of treatment (and 12 weeks if applicable) 2.2. For patients not receiving treatment with alemtuzumab: three months post-randomisation 2.3. For all patients: six months after randomisation (omitted if within four weeks of prior assessment) and 12 months after randomisation 3. Overall survival (OS) 4. Time to MRD relapse for patients who are or who become MRD negative 5. Safety and toxicity: measured from consent until 30 days after the last day of the last treatment with alemtuzumab for patients receiving treatment, and until six months after randomisation for patients not receiving treatment with alemtuzumab 6. Quality of life: measured at baseline and 3, 6, 12, 24 and 36 months after randomisation 7. Quality adjusted life years (QALYs) Please note that the timepoints above only refer to the proportion of patients with undetectable MRD at the six-month post-randomisation follow-up visit, response, safety and quality of life as the other outcomes are not measured at specific time points. | — |
Countries
United Kingdom
Outcome results
None listed