A Study of Decitabine Given Subcutaneously to Adults With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)

Summary

The purpose of this study is to determine the effectiveness and safety of two different dose schedules of DACOGEN® (decitabine) for Injection in patients with Myelodysplastic Syndromes (MDS).

Timeline

Start

2008-05

Primary completion

2012-03

Completion

—

Outcome

Met primary endpoint

paper The trial was terminated early on achievement of protocol-defined OIR superiority of schedule A over schedule B PMID 23733767 ↗

Publications

• Garcia-Manero G, Jabbour E, Borthakur G, Faderl S, Estrov Z, Yang H, Maddipoti S, Godley LA, Gabrail N, Berdeja JG, Nadeem A, Kassalow L, Kantarjian H. Randomized open-label phase II study of decitabine in patients with low- or intermediate-risk myelodysplastic syndromes. J Clin Oncol. 2013 Jul 10;31(20):2548-53. doi: 10.1200/JCO.2012.44.6823. Epub 2013 Jun 3.

Drugs

Indications