Randomized Phase II Trial Seeking the Most Promising Drug Association With Azacitidine- in Higher Risk Myelodysplastic Syndromes
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Remission, complete, partial or medullary after 6 cycles
Achievement of remission, complete, partial or medullary, according to the IWG 2006 criteria39 (see section 10 below) after 6 cycles
6 months
No
Pierre Fenaux, MD, PhD
Principal Investigator
Assistance Publique - Hôpitaux de Paris
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
P081225
NCT01342692
June 2011
June 2016
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