ACE-536-MDS-002 (Commands) (FL)

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) ESA in Native Subjects Who Require Red Blood Cell Transfusions

Study treatment

• Experimental arm:  luspatercept (ACE-536) 1.0 mg/kg subcutaneous every 3 weeks 
• Controle arm: epoetin alfa 450 IU/kg subcutaneous weekly

Inclusion criteria

• ≥ 18 years of age

• a documented diagnosis of MDS according to WHO 2016 classification that meets IPSS-R classification of very low, low, or intermediate risk disease, and  < 5% blasts in bone marrow

• an endogenous serum erythropoietin (sEPO) level of < 500 U/L

• requires RBC transfusions

• ECOG 0-2

Exclusion criteria

• Subject with the any of the following prior treatments:
  • Erythropoiesis-stimulating agents (ESAs)
  • Granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), unless given for treatment of febrile neutropenia
  • Disease modifying agents (eg, immune-modulatory drug [IMiDs such as lenalidomide]
  • Hypomethylating agents
  • Luspatercept (ACE-536) or sotatercept (ACE-011)
  • Immunosuppressive therapy for MDS
  • Hematopoietic cell transplant
• Subject with MDS associated with del(5q) cytogenetic abnormality or MDS unclassifiable (MDS-U) according to WHO 2016 classification
• Subject with myelodysplastic/myeloproliferative neoplasms (MDS/MPN) according to WHO 2016 classification
• Subject with secondary MDS
• Subject with known history of diagnosis of AML

Participating sites

• University Hospital Leuven Gasthuisberg
• ZNA Middelheim
• AZ Groeninge
• AZ KLINA
• CU Saint-Luc
• Grand Hopital de Charleroi