Untreated early stage Chronic Lymphocytic Leukaemia (CLL) (Binet stage A) with poor prognostic factors. MedDRA version: 9.1 Level: LLT Classification code 10008958 Term: Chronic lymphocytic leukaemia
Conditions
Interventions
Trade Name: Revlimid
Product Name: Lenalidomide
Pharmaceutical Form: Capsule, hard
Sponsors
The Christie NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Binet stage A CLL • 2 or more risk factors: - Unmutated IgVH locus (=98% homology to germline sequence) - CD38 expression (>7%) - Deletion of chromosome 11q22 (>20% by FISH) - Deletion of chromosome 17p13 (>10% by FISH) • Over 18 years old • Capable to provide written informed consent • ECOG performance status 2 years • Must agree to not share study lenalidomide with someone else • Must agree not to donate blood whilst taking the study drug and for one week after discontinuation of treatment • Female subjects of child bearing potential and all male subjects must agree to comply with the stipulations of the pregnancy prevention plan Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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 • Pregnant or lactating • Known positivity for human immunodeficiency virus (HIV) types 1 or 2 • 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: - Basal cell carcinoma of the skin - Squamous cell carcinoma of the skin - Carcinoma in situ of the cervix - Carcinoma in situ of the breast • Significantly abnormal renal or hepatic function - Creatinine clearance 3 x upper limit of normal (ULN) - Serum bilirubin > 34µmol/l) • Laboratory tumour lysis syndrome according to the Cairo-Bishop classification. Subjects may be enrolled when these abnormalities have been corrected. • Peripheral neuropathy (grade = 2) • Previous treatment for CLL • Previous treatment with Thalidomide or immunomodulatory derivative drugs (including lenalidomide) • Treatment with corticosteroids (for CLL or other indications) < 28 days from study entry • Evidence of Richter’s transformation • Unsupported absolute neutrophil count < 1x109/l or platelet count < 50x109/l not due to CLL • Active autoimmune haemolytic anaemia or thrombocytopenia • 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 |
|---|---|
| Main Objective: To determine the efficacy and tolerability of lenalidomide in the treatment of patients with poor risk early stage Chronic Lymphocytic Leukaemia (CLL). ;Secondary Objective: If treatment with lenalidomide is shown to be effective the secondary objective would be to conduct a randomised phase III trial to compare lenalidomide treatment with the current standard therapy (observation).;Primary end point(s): Disease response assessment by achievement of Minimal Residual Disease (MRD) negative complete remission (CR). | — |
Countries
United Kingdom
Outcome results
None listed