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 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
NCT ID:
NCT01496495
Eligibility Criteria:
Key Inclusion Criteria (Part 1 and Part 2):
* Diagnosis of MDS by bone marrow biopsy.
* International Prognostic Scoring System (IPSS) score of low or intermediate-1 risk MDS.
* May have received prior therapy for MDS.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
* Adequate liver and renal function.
* Additional criteria exist.
Key Exclusion Criteria (Part 1 and Part 2):
* History of bone marrow transplant.
* Treatment for MDS other than transfusions or a stable dose (≥ 4 weeks) of hematopoietic growth factors on the day of the first dose of study drug.
* Concomitant malignancies or previous malignancies with less than a 2-year disease-free interval at the time of enrollment.
* Treatment with an investigational medicinal product that is not expected to be cleared by the first dose of study drug or that has demonstrated to have prolonged side effects.
* Treatment with azacitidine or decitabine within 2 weeks prior to first dose of study drug.
* Chronic use (\> 2 weeks) of greater than physiologic doses of corticosteroids (dose equivalent to \> 20 mg/day of prednisone) within 4 weeks prior to first dose of study drug.
* Treatment with an immunomodulatory agent within 4 weeks prior to the first dose of study drug.
* Additional criteria exist.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01496495
Study Brief:
Protocol Section:
NCT01496495