Revlimid for AML with 13q Abnormality – pro

Revlimid is a derivative of thalidomide with less toxic side effects. A multicenter U.S. trial has reported hematologic activity of Revlimid in patients with myelodysplastic syndromes (MDS). The U.S. Food and Drug Administration has approved Revlimid for the treatment of low- to intermediate-risk MDS in patients who are transfusion-dependent associated with a 5q cytogenetic abnormality, with or without other cytogenetic abnormalities. There is a study in patients with a specific AML type:

Revlimid in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, July 2009
First Received: August 4, 2006 Last Updated: July 30, 2009 History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: Celgene Corporation
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00360672

Several patients with 13q abnormality with acute myeloid leukemia (AML) associated with trisomy 13 achieved a complete remission following treatment with Revlimid® (lenalidomide). These remain anecdotal reports and not a basis for approval.

It might also be effective in AML with 5q abnormality.

Fehniger TA, Byrd JC, Marcucci G, et al. single agent lenalidomide induces complete remission of acute myeloid leukemia in patients with isolated trisomy 13. Blood [early online publication]. September 29, 2008.

Farag SS, Archer KJ, Mrozek K, et al. Isolated trisomy of chromosomes 8, 11, 13 and 21 is an adverse prognostic factor in adults with de novo acute myeloid leukemia: results from Cancer and Leukemia Group B 8461. International Journal of Oncology.2008;21:1041-1051.

Möllgård L, Saft L, Treppendahl MB, Dybedal I, Nørgaard JM, Astermark J, Ejerblad E, Garelius H, Dufva IH, Jansson M, Jädersten M, Kjeldsen L, Linder O, Nilsson L, Vestergaard H, Porwit A, Grønbæk K, Hellström-Lindberg E. Clinical effect of increasing doses of lenalidomide in high-risk myelodysplastic syndrome and acute myeloid leukemia with chromosome 5 abnormalities.Haematologica. 2011 Jul;96(7):963-71.

Pollyea DA et al, Sequential azacitidine plus lenalidomide combination for elderly patients with untreated acute myeloid leukemia.Haematologica. 2013 Apr;98(4):591-6.

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