5 Day Versus 7 Day Azacitidine in Lower Risk Myelodysplastic Syndrome
Status:
Unknown status
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
Approved dosing schedule of azacitidine for myelodysplastic syndrome (MDS) is 75 mg/m^2/day
subcutaneous for 7 consecutive days every 28 days, which is based on the data from standard
chemotherapy regimen and a Phase I safety clinical trial. Since the optimal dosage of this
drug has not been found yet, it remains as a subject of clinical study that needs to be
examined. If initial toxicity is minimized by developing dosage/regimen that replaces the
standard therapy, it will be possible to provide continuous treatment with increased
convenience by patients and treating physicians as well as improvement for safety in elderly
patients or those with serious cytopenia. In addition, it is expected to lead to a better
response by strictly keeping a treatment schedule.
Recent US study showed that 5-day regimen showed similar treatment results, but retrospective
data from Spain showed lower response rate in 5-day regimen. Considering the recent
circumstances around dosage and schedule of azacitidine in lower risk MDS, a Phase II
clinical trial is planned in lower risk MDS patients in order to explore the efficacy in
5-day treatment by comparing prospectively with 7-day standard regimen.