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:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2025-12-25 @ 4:34 AM
NCT ID:
NCT02008318
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of MDS based on the World Health Organization (WHO) criteria
* Participants with 5q deletions are allowed only if they have failed or are intolerant of lenalidomide treatment
* Participants must have a Revised International Prognostic Scoring System (IPSS-R) category of very low-, low-, or intermediate-risk disease
* In the 8 weeks prior to registration, participants in phase 2 should have anemia with Hb ≤10.0 g/dL (based on the average of 2 baseline measurements and untransfused for at least 1 week) with or without red blood cell (RBC) transfusion dependence confirmed for a minimum of 8 weeks before enrollment
* For phase 3, participants should have anemia with RBC transfusion dependence confirmed within 8 weeks before enrollment
* Performance status ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale
Exclusion Criteria:
* No history of moderate or severe cardiac disease
* No prior history of acute myeloid leukemia (AML)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02008318
Study Brief:
Protocol Section:
NCT02008318