Chronic lymphocytic leukaemia (CLL) Cancer Leukaemia
Conditions
Interventions
Patients who have previously achieved a minimal residual disease (MRD) negative remission and have relapsed at a molecular level, or who have a low level of MRD following conventional therapy will rec
Sponsors
Leeds Teaching Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. At least 18 years old 2. Written informed consent 3. Previous confirmation of B-cell CLL with a characteristic immunophenotype on peripheral blood flow cytometry 4. Creatinine and bilirubin <2 x upper limit of normal unless secondary to direct infiltration of the liver by CLL or haemolysis 5. Must have achieved a complete remission or good partial remission after therapy for CLL 6. At least six months since completing last therapy for CLL 7. Have detectable MRD, as shown by peripheral blood or bone marrow involvement or have attained an MRD negative remission. The latter group is eligible for registration and three-monthly monitoring for MRD relapse
Exclusion criteria
Exclusion criteria: 1. Lymph nodes of 2 cm or greater in maximum diameter 2. Known Human Immunodeficiency Virus (HIV) positive 3. Active infection 4. Past history of anaphylaxis following exposure to rat or mouse derived Commonly Deleted Region (CDR)-grafted humanised monoclonal antibodies 5. Use of prior investigational agents within six weeks 6. Pregnancy or lactation 7. Central Nervous System (CNS) involvement with CLL 8. Mantle cell lymphoma 9. Other severe, concurrent diseases or mental disorders 10. Active secondary malignancy 11. Persisting severe pancytopenia due to previous therapy rather than disease (neutrophils <0.5 x 109/l or platelets <50 x 109/l) 12. Patients previously treated with allogeneic Stem Cell Transplantation (SCT) 13. Patients who previously failed alemtuzumab therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Rate of achieving MRD negativity in patients with low levels of MRD following conventional therapy or who relapse at an MRD level after a previous MRD negative remission 2. Safety of alemtuzumab in the MRD positive setting | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical response to alemtuzumab therapy by National Cancer Institute (NCI) Criteria 2. Overall survival 3. Pharmacokinetic profile of alemtuzumab in the MRD setting 4. Safety and efficacy of repeated dosing as required to achieve sustained MRD negativity Outcome of additional Monitoring Investigation (patients who are MRD negative at registration): 1. Time to MRD relapse 2. Effect of alemtuzumab used in a consolidation/maintenance approach on the expression of CD52 on CLL cells | — |
Countries
England, United Kingdom
Outcome results
None listed