Study #2018-0179
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) versus Epoetin alfa for the Treatment of Anemia due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in ESA Naive Subjects who
MD Anderson Study Status
Enrolling
Treatment Agent
Luspatercept, Epoetin alfa
Description
The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is an interventional active-controlled, open-label, randomized Phase 3 study to compare the efficacy and safety of luspatercept (ACE-536) versus epoetin alfa for the treatment of anemia due to IPSS-R very low, low or intermediate risk MDS in ESA naïve subjects who require RBC transfusions. The study is divided into the Screening Period, a Treatment Period and a Post-Treatment Follow-up Period.
Information and next steps
Disease:
Myelodysplastic Syndromes
Study phase:
III
Physician name:
Guillermo Garcia-Manero
Department:
Leukemia
For general questions about clinical trials:
1-877-632-6789
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