Trial Information

A Phase II Multi-center Study of 5-AZA-2'-Deoxycytidine (Decitabine) Single Agent in Taiwanese Patients With Myelodysplastic Syndrome (MDS)

This is an open-label, multicenter, single-arm study in Taiwan. The recommended decitabine
dose is 20mg/m² administered intravenously over 1 hour, once daily for 5 consecutive days,
of a 4-week cycle. The dose can be reduced, delayed, or discontinued by the investigators if
certain toxicities occur. Responses to decitabine are sometimes only observed after multiple
courses of treatment. Therefore, to maximize a patient's chance to respond, a patient whose
disease has not progressed and who is tolerating the treatment, should receive at least 8
cycles of decitabine. If, in the opinion of the treating physician, there is continued
clinical benefit from the treatment, absence of progressive disease and absence of
unacceptable toxicity, at the time the patient reaches 8 cycles, treatment can be continued
beyond 8 cycles, as long-term extension phase treatment. Any patient who achieves a complete
remission should be treated for at least 2 more cycles after first documentation of CR
(Complete Response), after which treatment can be discontinued. In case of relapse,
off-treatment after prior CR, re-treatment with decitabine is allowed, and can be considered
at the discretion of the treating physician. The information collected in the long-term
extension phase and at time of re-treatment will be summarized separately. Response to
treatment will be based on International Working Group (IWG) 2006 response criteria.Safety
will be assessed by the monitoring of adverse events, physical examinations, vital signs
measurements, hematology and clinical chemistry tests. The study will include patients
diagnosed with myelodysplastic syndrome (according to WHO classification, but including
patients with Bone Marrow blast counts of 20-30% for whom no progression was observed during
a 1 month observation period), both de novo or secondary, and including previously treated
and untreated patients. Eligible subjects must sign an informed consent and meet all
inclusion criteria and have none of the exclusion criteria. The secondary objectives are to
evaluate the safety and tolerability of decitabine, hematologic improvement, cytogenetic
response rates, time to acute myeloid leukemia progression or death, overall survival,
transfusion requirements and transfusion independence, duration and reasons for
hospitalization and quality of life assessment. The recommended decitabine dose is 20mg/m²
administered intravenously over 1 hour, once daily for 5 consecutive days of a 4-week cycle.
To maximize a patient's chance to respond, a patient whose disease has not progressed and
who is tolerating the treatment, should receive at least 8 cycles of decitabine.