AML Len5 Version 1.0

• Research type

  Research Study

• Full title

  A 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.

• IRAS ID

  4913

• Sponsor organisation

  Leeds Teaching Hospitals NHS Trust

• Eudract number

  2008-004891-28

• ISRCTN Number

  ISRCTN58492795

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Myelodysplastic syndromes and acute myeloid leukaemia are rare but serious bone marrow cancers. Abnormality of chromosome 5 in bone marrow cells has a poor prognosis. Lenalidomide is a novel drug, modified from thalidomide, which can improve bone marrow function in patients with "low-risk MDS" and a partial abnormality of chromosome 5 (del5q; deletion of part of the chromosome's long arm). We now propose to test Lenalidomide in "high-risk" MDS and AML patients with chromosome 5 abnormalities and who are considered fit for intensive chemotherapy. High-risk MDS includes patients with loss of the entire chromosome 5, or with >5% bone marrow blast (leukaemia-like) cells. Patients with AML are defined as having >20% bone marrow blast cells. Patients will first receive Lenalidomide alone to attempt to achieve a response with less toxic effects than the conventional approach with intensive chemotherapy alone. If this is achieved, patients will then receive "consoldation" therapy with a combination of lenalidomide and intensive chemotherapy. If remission is not achived with lenalidomide alone, patients will immediately receive the combination therapy. Patients who remain in remission after consolidation therapy will be offered a stem cell transplant if they have a donor or maintenance therapy for 12 months if no donor. Blood and bone marrow samples will also be taken from patients who consent for research studies to include changes in the leukaemia stem cells and proteins in the serum with this novel therapy.The study is designed to test the safety of the combination approach using Lenalidomide plus intensive chemotherapy and the results will be used to subsequently plan a larger study to test if the addition of Lenalidomide is better than the currently used chemotherapy alone.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  08/H1306/166

• Date of REC Opinion

  23 Feb 2009

• REC opinion

  Further Information Favourable Opinion