Pilot safety/tolerability study of Lenalidomide administered as monotherapy and in combination with standard chemotherapy for Acute Myeloid Leukaemia/high-risk myelodysplastic syndrome with structural abnormalities of chromosome 5
- Conditions
- Acute myeloid leukaemia, high-risk myelodysplastic syndrome, chromosome 5 cytogenetic abnormalitiesCancerMyeloid leukaemia
- Registration Number
- ISRCTN58492795
- Lead Sponsor
- eeds Teaching Hospitals NHS Trust (UK)
- Brief Summary
2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24371786 results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 14
1. Patients diagnosed with primary/relapsed/refractory AML (as defined by World Health Organization [WHO]) or high risk MDS (defined as International Prognostic Scoring System [IPSS] Int-2/High) with chromosome 5 cytogenetic abnormalities
2. Aged 18 years old, either sex
3. Considered suitable for intensive chemotherapy
4. Capable of understanding and complying with protocol requirements
5. Written informed consent
1. Use of prior investigational agents within four weeks
2. The subject has received lenalidomide in a previous clinical study or as a therapeutic agent
3. The subject has a history or clinical manifestations of human immunodeficiency virus (HIV) or other active infection
4. The subject has a history of hypersensitivity or allergies to lactose
5. If female, the subject is pregnant or lactating
6. The subject has another active malignancy
7. The subject has other severe concurrent disease or mental illness
8. Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
9. Myocardial dysfunction (as defined by left ventricular ejection fraction less than 50%)
10. Creatinine clearance (Cockroft) less than 60 mls/min
11. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) greater than 3 x upper limit of normal (ULN)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method