Myelodysplastic Syndromes Clinical Trial
Official title:
A Phase 4, Open-Label, Single-Arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes.
The primary purpose of this study is to determine the effectiveness and safety of azacitidine in the treatment of Taiwanese subjects with higher-risk Myelodysplastic Syndrome (MDS).
The study has 3 phases which include the Screening Phase, the Treatment Phase, and the
Post-Treatment Phase and outlined as follows:
Screening Phase:
Subjects will provide informed consent prior to undergoing any study-related procedures.
Screening procedures are to take place within 28 days prior to the initiation of azacitidine
treatment (Day 1, Cycle 1). Subject eligibility will be based on central pathology review.
Bone marrow aspirate and bone marrow biopsy will be collected at screening and sent for
morphological assessment by a central pathology reviewer prior to the subject receiving IP.
The central pathology reviewer will document the MDS classification according to the FAB and
WHO criteria (Appendix A and B, respectively).
A standard cytogenetic metaphase preparation will be prepared from the bone marrow aspirate
and sent to the local or central laboratory (for sites without local analysis capability) for
the cytogenetic analysis prior to receiving IP.
The IPSS score will be calculated using the central reviewer's pathology report for bone
marrow blast percentage, local cytogenetic assessment for karyotype, and central laboratory
report for number of cytopenias (Appendix D).
Treatment Phase:
The first dose of azacitidine for each subject begins on Day 1 of Cycle 1. All subjects will
receive azacitidine 75 mg/m2/day SC for 7 days every 28 days for up to 6 cycles, unless they
are discontinued from treatment. Visits during the treatment phase are to be scheduled weekly
for the first 2 cycles, then every other week for all subsequent cycles throughout the rest
of the study. Safety and efficacy measures are to be performed weekly, every other week,
every 4 weeks, or at 24 weeks, depending on the procedure.
Post-Treatment Phase:
All discontinued subjects, regardless of reason for discontinuation, should undergo
end-of-study procedures at the time of study discontinuation. Subjects will have a follow-up
visit for the collection of adverse events up to 28 days after last IP dose.
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