MDS Clinical Trial
Official title:
Randomized Phase II Trial Seeking the Most Promising Drug Association With Azacitidine- in Higher Risk Myelodysplastic Syndromes
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.
The main objective of this phase II randomized trial is to identify, among 3 combinations of
Azacitidine and another drug evaluated simultaneously, the most promising combination(s) for
the treatment of higher risk MDS (IPSS Int-2 and High) compared to Azacitidine alone. The 3
tested drugs in combination with Azacitidine are: Valproic Acid, Lenalidomide and Idarubicin.
The aim of this trial is to identify, in a situation where several potentially interesting
drugs tested in combination with AZA exist, the most promising combination(s) based on
efficacy compared to azacitidine alone, based on a two-stage design that allows a formal
efficacy comparison between the K=3 investigational treatment groups and the control group.
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