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A Single Arm Phase II Study to Investigate the Use of Lenalidomide in the Treatment of Patients With Early Stage CLL Associated With Poor Prognostic Factors

Phase 2
18 Years
Not Enrolling
Chronic Lymphocytic Leukaemia

Thank you

Trial Information

A Single Arm Phase II Study to Investigate the Use of Lenalidomide in the Treatment of Patients With Early Stage CLL Associated With Poor Prognostic Factors

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

- Life expectancy > 2 years

- Must agree to not share 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 childbearing potential and all male subjects must agree to comply
with the stipulations of the pregnancy prevention plan.

Exclusion Criteria:

- Current or recent (within the last 1 month) participation in another clinical trial
investigating the action of an investigational medicinal product for the treatment of

- 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

- 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 < 60ml/min,
serum aspartate aminotransferase (AST) > 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

- Treatment with corticosteroids (for CLL or other indications) < 28 days from study

- Evidence of Richter's transformation

- Unsupported absolute neutrophil count < 1x109/l or platelet count < 50x10*9/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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete Remission with clearance of Minimal Residual Disease (MRD)

Outcome Time Frame:

6 months (or earlier if clinically indicated)

Safety Issue:


Principal Investigator

Adrian Bloor

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Christie NHS Foundation Trust


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

May 2010

Completion Date:

December 2011

Related Keywords:

  • Chronic Lymphocytic Leukaemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid