Study of Decitabine Alone or in Combination With Valproic Acid and All-trans Retinoic Acid in Acute Myeloid Leukemia
Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
Summary
AML of the older patient constitutes a major unmet clinical need since the large majority
will not be found eligible for induction chemotherapy. Reasons for this decision include host
factors (comorbidities, reduced performance status, functional limitations due to age),
leading to often poor tolerance of repeated chemotherapy courses and the unfavorable biology
underlying this disease in older patients. Low dose Decitabine has shown very promising
efficacy in high-risk MDS and is therefore a very promising approach also in older AML
patients. Preliminary results from several centres have demonstrated excellent feasibility
and good efficacy of this treatment. Therefore the investigators intend to investigate the
effects of two drugs added onto low-dose Decitabine which have shown very promising
synergistic effects in vitro and for which preliminary results indicate that the combination
with low-dose Decitabine is very feasible.