An Open-label, Multi-center, Phase IIIb Study for Decitabine in Patients With Myelodysplastic Syndrome (MDS)
This is a prospective (look forward using periodic observations collected predominantly
following patient enrollment), open-label (all people involved in the study know the
identity of the assigned drug), Phase IIIb study to evaluate the efficacy and safety of
decitabine in the treatment of myelodysplastic syndrome (MDS). Patients are randomized
(study drug assigned by chance) in 1:1 ratio to receive treatment with decitabine either
3-day or 5-day course of therapy. When a minimum of 30 patients are reached for 3-day course
of therapy, the rest of the patients will all be enrolled into 5-day course of therapy. Each
patient in the study treated for a minimum of 4 cycles; however, a complete or partial
response may take longer than 4 cycles. The entire study duration for each patient will be
approximately two years. Safety will be evaluated for each patient by monitoring of adverse
events, physical examinations, vital signs measurements, electrocardiogram, hematology and
clinical chemistry testing.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (ORR)
The ORR is measured by complete response (CR)+ marrow CR (mCR)+partial response (PR) as per International working group for MDS (IWG 2006) criteria. End of treatment is defined as 30 days after last dose of study drug.
From the date of randomization to the date of disease progression or death, whatever comes first, assessed up to 2 years
Xian-Janssen Pharmaceutical Ltd Clinical Trial
Xian-Janssen Pharmaceutical Ltd.
China: Food and Drug Administration