A Phase 2 Open-Label Study to Evaluate Etavopivat for the Treatment of Anemia in Patients with Myelodysplastic Syndromes (MDS).

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Myelodysplastic Syndromes (mds)
  • Age: Between 18 years - 100 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Documented diagnosis of idiopathic/de novo MDS according to World Health Organization (WHO) classification (see Appendix C) that meets the IPSS-R classification (see Appendix B) of very low, low, or intermediate risk disease, and: • < 5% blasts and no Auer rods in bone marrow based on local pathology review • < Intermediate risk cytogenetic abnormalities per IPSS-R (see Appendix B). 2. Anemia defined as: • NTD: Subjects with mean Hb concentration < 10.0 g/dL of 2 measurements (1 performed within 3 days prior to Day 1 and the other performed 7 to 28 days prior to Day 1, not influenced by RBC transfusion within 7 days of measurement) and < 3 RBC transfusions for anemia in the prior 16 weeks before Day 1 of etavopivat dosing OR • Transfusion dependent: Subjects having received = 3 units of RBCs for the treatment of anemia within 16 weeks prior to Day 1. 3. Eastern Cooperative Oncology Group performance status of = 2 (see Appendix D).

You may not be eligible for this study if the following are true:

  • 1. MDS associated with del 5q cytogenetic abnormality and known TP53 abnormality 2. Therapy-associated MDS (eg. t-MDS) that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases 3. Known history of acute myeloid leukemia (AML). 4. Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding 5. Absolute neutrophil count < 500/µL (0.5 × 109/L).

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