Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT03303066
Eligibility Criteria:
Key Inclusion Criteria:
* Diagnosis of primary MDS classified as very low, low or intermediate risk with \<5% blasts (documented within 12 weeks prior to Day 1)
* Screening Hb \<10 g/dL and ≥6g/dL
* Transfusion independent defined as no red blood cell transfusions within 12 weeks of Day 1
* Erythropoiesis-stimulating agent (ESA)-naïve (not within 30 days of Day 1)
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Key Exclusion Criteria:
* Diagnosis of secondary MDS
* Significant myelofibrosis (\>2+fibrosis)
* Prior therapy with azacitidine, decitabine, antithymocyte globulin, cyclosporine, thalidomide, or lenalidomide within 12 weeks prior to Day 1
* Baseline erythropoietin level of \>400 units (U)/liter (L)
* Clinically significant anemia due to non-MDS etiologies
Note: Other inclusion and exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03303066
Study Brief:
Protocol Section:
NCT03303066