Revlimid® Early Stage Poor prognosis Chronic lymphocytic leukaemia (CLL) Trial

Phase 2

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Haematological Oncology; Disease: Leukaemia (chronic); Cancer; Leukaemia (chronic)

• Registration Number: ISRCTN84606869
• Lead Sponsor: Christie NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-31
• Study Completion: 2011-11-24
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified