Low-dose azacytidine, pioglitazone and retinoic acid in ≥ 60 years patients with acute myeloid leukaemia refractory to chemotherapy (AML-ViVA)
The AML-ViVA trial was set after haematologists in Regensbrug in Germany treated 5 patients with refractory acute myeloid leukaemia (AML) with an off-label treatment regimen called the ‘ViVA’ regimen.
ViVA combines a drug approved to treat another type of leukaemia (all-trans retinoic acid) and an antidiabetic drug (pioglitazone), both known to bind to nuclear receptors and induce cell differentiation (meaning to transform leukaemia cells into normal cells). To those 2 drugs, a standard leukaemia drug (azacytidine) is added at a lower dose than usual.
All 5 patients got better thanks to the treatment and a trial was set up with the support of the Anticancer Fund.
The first results of this trial have just been presented at the major haematology conference, the ASH conference, in Orlando in the USA. The treatment is safe in this very fragile population and 3 out of 10 patients had a complete response. One additional patient had a stabilisation of his disease for 14 months. The second part of the trial was supposed to compare the ViVA regimen to the standard dose azacytidine but it won’t happen because of issues with the company providing the azacytidine (and some funding) for the trial.
The investigators are looking for alternative solutions to explore further the ‘ViVA’ regimen in AML. The Anticancer Fund is helping them in this endeavour.