Topic: National Cancer Research Network
Conditions
Interventions
Oral lenalidomide at escalating dose for 3 x 28 day cycles (2.5 mg daily, 5 mg daily, 10 mg daily), then maintenance phase at 10 mg (or maximum tolerated dose).
Sponsors
Christie NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Binet stage A CLL 2. Two or more risk factors: 2.1. Unmutated IgVH locus (=98% homology to germline sequence) 2.2. CD38 expression (greater than 7%) 2.3. Deletion of chromosome 11q22 (greater than 20% by FISH) 2.4. Deletion of chromosome 17p13 (greater than 10% by FISH) 3. Over 18 years old, either sex 4. Capable to provide written informed consent 5. Eastern Cooperative Oncology Group (ECOG) performance status less than 2 6. Life expectancy greater than 2 years 7. Must agree to not share study lenalidomide with someone else 8. Must agree not to donate blood whilst taking the study drug and for one week after discontinuation of treatment 9. Female subjects of child bearing potential and all male subjects must agree to comply with the stipulations of the pregnancy prevention plan
Exclusion criteria
Exclusion criteria: 1. Current or recent (within the last 1 month) participation in another clinical trial investigation the action of an investigational medicinal product for the treatment of CLL 2. Pregnant or lactating 3. Known positivity for human immunodeficiency virus (HIV) types 1 or 2 4. Prior history of malignancies, other than CLL, unless the subject was treated with curative intent and has been free of the disease for 3 years. Exceptions include the following: 4.1. Basal cell carcinoma of the skin 4.2. Squamous cell carcinoma of the skin 4.3. Carcinoma in situ of the cervix 4.4. Carcinoma in situ of the breast 5. Significantly abnormal renal or hepatic function: 5.1. Creatinine clearance less than 60 ml/min (measured or calculated) 5.2. Serum aspartate aminotransferase (AST) greater than 3 x upper limit of normal (ULN) 5.3. Serum bilirubin greater than 34 µmol/l 6. Laboratory tumour lysis syndrome according to the Cairo-Bishop classification. Subjects may be enrolled when these abnormalities have been corrected. 7. Peripheral neuropathy (grade = 2) 8. Previous treatment for CLL 9. Previous treatment with Thalidomide or immunomodulatory derivative drugs (including lenalidomide) 10. Treatment with corticosteroids (for CLL or other indications) less than 28 days from study entry 11. Evidence of Richter's transformation 12. Unsupported absolute neutrophil count less than 1 x 10^9/l or platelet count less than 50 x 10^9/l not due to CLL 13. Active autoimmune haemolytic anaemia or thrombocytopenia 14. Any other medical or psychological condition that in the view of the investigator would be likely to impact compliance with the protocol or interfere with trial treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission with clearance of minimal residual disease (MRD). Response to treatment to be assessed continually, with a more detailed assessment after 6 months of treatment (or earlier if clinically indicated). For patients in complete remission clearance of MRD is assessed every 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety and tolerability of treatment, assessed continually throughout treatment by collection of adverse event data, blood results, etc. 2. Event free survival, assessed each time patients are seen - at least once per month during treatment with study drug and then annually once off study drug and in long-term follow-up 3. Time to next treatment, assessed each time patients are seen - at least once per month during treatment with study drug and then annually once off study drug and in long-term follow-up | — |
Countries
England, United Kingdom
Outcome results
None listed