A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo for the Treatment of Anemia Due to the IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions.

Conditions

Leukemia, not otherwise specified | Leukemia, other | Myeloid and Monocytic Leukemia

Phase III

What is the purpose of this trial?

The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in subjects with anemia due to IPSS-R very low, low, or intermediate MDS with ring sideroblasts who require RBC transfusions.

  • Trial with
    Celgene Corporation
  • Start Date
    04/25/2019
  • End Date
    11/20/2018

I'm interested in volunteering

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 877.978.8348

Trial Image
  • Last Updated
    05/05/2019
  • Study HIC
    #2000023418