The Efficacy of Azacitidine +/- Lenalidomide in High-risk Myelodysplastic Syndrome (MDS)and Acute Myeloid Leukemia (AML) With Del(5q).

Summary

The proposed phase II trial is a multicenter, randomized, open-label study that will evaluate the efficacy and safety of azacitidine alone or in combination with lenalidomide in high-risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) with a karyotype including del(5q). The primary objective will be to evaluate the efficacy in terms of response according to International Working Group (IWG) criteria for MDS and AML after 6 cycles of azacitidine or azacitidine + lenalidomide treatment, or at end of study if this occurs at an earlier time point.

Timeline

Start

2012-03

Primary completion

2014-07

Completion

2014-11

Publications

• Rasmussen B, Nilsson L, Tobiasson M, Jadersten M, Garelius H, Dybedal I, Gronbaek K, Ejerblad E, Lorenz F, Flogegard M, Marcher CW, Cavalier L, Ebeling F, Olsnes AM, Norgaard JM, Saft L, Mollgard L, Hellstrom-Lindberg E, Schlegelberger B, Gohring G. Influence of Cytogenetics on the Outcome of Patients With High-Risk Myelodysplastic Syndrome Including Deletion 5q Treated With Azacitidine With or Without Lenalidomide. Genes Chromosomes Cancer. 2025 Feb;64(2):e70029. doi: 10.1002/gcc.70029.

Drugs

Indications