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 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
NCT ID:
NCT00113893
Eligibility Criteria:
Inclusion Criteria:
* Patients with a diagnosis of low/intermediate-1 MDS (for at least 12 weeks)
* Patients with anemia (average Hemoglobin \< 10 g/dL or \> or = to 4 units of Red Blood Cell counts in the last 8 weeks)
* Patients who have failed prior erythropoietin treatment
* Patients with an ECOG (Eastern Collaborative Oncology Group) score of 0, 1 or 2
Exclusion Criteria:
* Patients with a International Prognostic Scoring System risk category high/intermediate-2
* Patients with treatment-related MDS associated with radiation, chemotherapy, and/or autologous transplant
* Patients with myelosclerosis (or myelofibrosis) occupying \> 30 % marrow space
* Patients who have received decitabine (DacogenTM) for MDS
* Patients who have received lenalidomide (RevlimidTM), steroids, erythropoietin, hydroxyurea, or growth factors within 4 weeks before study drug administration
* Patients who have received thalidomide within 8 weeks before study drug administration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00113893
Study Brief:
Protocol Section:
NCT00113893