Acute myeloid leukaemia, high-risk myelodysplastic syndrome, chromosome 5 cytogenetic abnormalities Cancer Myeloid leukaemia
Conditions
Interventions
For patients with greater than 5% blasts at trial entry:
Lenalidomide monotherapy:
Lenalidomide will be administered orally at 10 mg daily for 21 days. Bone marrow exa
Sponsors
Leeds Teaching Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is safety and tolerability of the combination therapy, assessed by two outcomes: early death rate and the proportion of patients recovering their platelets and surviving by 42 days after chemotherapy. If the treatment is found to be safe and tolerable for BOTH of these endpoints, then we will consider the short term efficacy in terms of complete remission rate as a third primary endpoint and we will use this to determine whether or not to proceed to a phase III trial. The early death rate and proportion of patients recovering platelets and surviving will be assessed at four points throughout the trial; after 10 patients, 19 patients, 30 patients, and 39 patients have been recruited. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to recovery of neutrophils 2. Blood product usage 3. Length of time spent in hospital | — |
Countries
England, United Kingdom
Outcome results
None listed