A Trial of Lenalidomide & Azacitidine in Low Risk Myelodysplastic Syndromes
Status:
Terminated
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
This phase II study will evaluate the safety and efficacy of combining two active
agents;Revlimid® (lenalidomide) and low dose Vidaza® (azacitidine) for the treatment of
patients with low to intermediate-1 MDS excluding patients with 5 q deletion. The rationale
for adding Vidaza® (azacitidine) after 3 months of revlimid monotherapy is that combination
therapy will result in higher response rates, and potentially longer response duration than
that achieved with either agent.
STUDY OBJECTIVES:
Primary:
To determine the safety and tolerability of the combination of Revlimid® (lenalidomide) and
low dose Vidaza® (azacitidine) in patients with low - intermediate-1 risk MDS non 5 q
deletion who have not responded after 3 months of Revlimid® (lenalidomide) monotherapy
Secondary:
To determine the response rate in patients with low - intermediate-1 risk MDS non 5 q
deletion receiving Revlimid® (lenalidomide) in combination with low dose Vidaza®
(azacitidine), as defined by the IWG 2006 Revised Response Criteria