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 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT01009502
Eligibility Criteria:
Inclusion Criteria:
* Documented myelodysplastic syndromes (MDS), including therapy-related MDS
* Meets 1 of the following criteria:
* Refractory to prior azacitidine or decitabine
* Did not tolerate treatment with azacitidine or decitabine due to cytopenias or other side effects
* Not a candidate for azacitidine or decitabine due to cytopenias or other medical conditions that would contraindicate nucleoside analogues
* Refused treatment with azacitidine or decitabine
* Life expectancy ≥ 16 weeks
* Not pregnant or nursing
* No B12 deficiency, folate deficiency, or pyridoxine responsive anemia as confirmed by relevant laboratory testing
* No prolongation of QTc or ventricular ectopic beats on EKG
* No evidence of cardiac disease
* No active infection AND afebrile
* More than 21 days since prior azacitidine or decitabine
* More than 21 days since other prior treatment for MDS (e.g., thalidomide, valproic acid, or other agents as part of a clinical trial)
* Prior cytokines (e.g., erythropoietin, G-CSF, and GM-CSF) allowed
* Prior chemotherapy and/or radiotherapy for solid tumors or lymphoma allowed provided there is no evidence of active disease from the prior malignancy
Exclusion Criteria:
* Prior treatment for leukemia (e.g., acute myeloid leukemia, chronic myelogenous leukemia, acute lymphocytic leukemia, or chronic lymphocytic leukemia)
* Concurrent cytokines
* Concurrent antileukemic treatment, including bone marrow transplantation and radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01009502
Study Brief:
Protocol Section:
NCT01009502