Best Promising Drug Association With Azacitidine in Higher Risk Myelodysplastic Syndromes
Status:
Unknown status
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
Summary
In order to improve the overall survival benefit observed with AZA in higher risk MDS, its
combination with other active drugs in MDS must be tested.
Among drugs that have demonstrated to be active as a single agent in MDS and have preclinical
potential additive or synergistic activity with AZA are Histone deacetylase (HDAC) inhibitors
including Valproic acid, Lenalidomide and idarubicin. Phase I studies have already been
conducted or are being conducted combining those agents to demethylating agents, showing a
low toxicity profile and significant responses in high risk MDS. In this phase II randomized
trial, we want to identify the most promising combination of Azacitidine and another drug
(among 3 drugs: Valproic acid, Lenalidomide and Idarubicin) in higher risk MDS, by comparison
to Azacitidine alone. Of note, based on efficacy and toxicity, one or several combinations
may be stopped, and others, previously tested in phase I trials, included after protocol
amendment.