ACE-536-MDS-002 (Luspatercept) – Clinical Trial Open to Recruitment

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ACE-536-MDS-002 (Luspatercept)

  1. SUB-TYPE OF MDS:Lower Risk MDS patients who require red cell transfusions but have not received Erythropoietin
  2. SEVERITY OF MDS: IPSS-R Very Low, Low or Intermediate Risk MDS
  3. NAME OF DRUG: Luspatercept
  4. Aims and benefits: To compare the safety and efficacy of Luspatercept versus epoetin alfa for treating anaemia in patients who require red cell transfusions.
    Luspatercept promotes red blood cell formation by regulating the growth of red blood cells during the late-stage of their development. It works differently to erythropoietin.
    This is a Phase 3 Randomized Study between Luspatercept and Epoetin alfa.

  1. Primary outcome measures: 
    To determine the proportion of patients who become red cell transfusion free over the first 24 weeks from randomization.
  2. Secondary outcome measures:
    To establish the length of time it takes for patients to achieve improvements in haemoglobin and determine information about adverse events and how Luspatercept is distributed within the body.
  3. Basic inclusion criteria:
    • IPSS-R classification of very low, low, or intermediate risk disease, and < 5% blasts in the bone marrow
    • Serum erythropoietin level of < 500 U/L.
    • Require regular red cell transfusions
    • ECOG performance of 0 – 2 at screening
  4. Basic exclusion criteria:
    • Prior treatments with Erythropoiesis-stimulating agents (ESAs), Granulocyte colony-stimulating factor (G-CSF), Disease modifying agents (eg, immune-modulatory drug such as lenalidomide (with some exceptions), Hypomethylating agents (with some exceptions), Luspatercept (ACE-536) or sotatercept (ACE-011), Immunosuppressive therapy for MDS, stem cell transplant
    • Myelodysplastic/Myeloproliferative neoplasms (MDS/MPN) overlap syndromes
    • Diagnosis of secondary MDS
    • Significant myelofibrosis
    • MDS associated with 5q(del) abnormality
    • History of diagnosis of AML
    • Clinically significant anaemia due to other causes (unrelated to MDS)
  5. Trial sites/locations and name of physician in charge of trial (none are currently recruiting):
    • Aberdeen Royal Infirmary
    • Birmingham Heartlands Hospital
    • Royal Bournemouth Hospital
    • University of Oxford Headington
    • The Leeds Teaching Hospitals NHS Trust
    • St James's University Hospital
    • Lincoln County Hospital
    • Kings College Hospital
    • Christie Hospital NHS Trust

Please read information and always discuss trial information with your own physician.

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