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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT00796003
Eligibility Criteria:
Inclusion Criteria:
* Myelodysplastic syndrome (de novo or secondary) fitting any of the recognized French-American-British classifications: refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia with white blood cells less than 13,000 /mm3
* International Prognostic Scoring System (IPSS) greater than or equal to 0.5 (Intermediate-1, Intermediate-2 or high risk) by bone marrow assessment and bone marrow cytogenetics within 28 days before study registration
* 20 years or older
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Normal renal and hepatic function
Exclusion Criteria:
* Acute Myeloid Leukemia (AML) with bone marrow blasts greater than or equal to 30%
* Participants with a history of high-dose cytarabine (Ara-C) therapy (greater than 1,000 mg/m2/day)
* Participants administered adrenal cortex hormones or anabolic hormones within 7 days of study initiation
* Participants who have received a colony stimulating factor (CSF) formulation within 7 days of study initiation
* Active double cancer
* Uncontrolled cardiac disease or cognitive heart failure
* Uncontrolled restrictive or obstructive pulmonary disease
* Uncontrolled diabetes mellitus
* Active viral or bacterial infection
* Known positive serology for Human immunodeficiency virus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT00796003
Study Brief:
Protocol Section:
NCT00796003