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 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT00812968
Eligibility Criteria:
Inclusion Criteria:
* Must understand and voluntarily sign an informed consent form.
* Age ≥ 20 years at the time of signing the informed consent form.
* Must be able to adhere to the study visit schedule and other protocol requirements.
* Diagnosis of Myelodysplastic Syndrome (MDS) that meets International Prognostic Scoring System (IPSS) criteria for low- or intermediate-1-risk disease associated with a deletion 5(q31-33) abnormality
* Symptomatic anemia secondary to MDS defined as:Untransfused Hb level \< 10.0 g/dL and a Functional Assessment of Cancer Therapy (FACT)-anemia subscale score of ≤ 74 or Transfusion dependent anemia
Exclusion Criteria:
* Pregnant or lactating females.
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
* Prior therapy with lenalidomide.
* Patients with any of the following laboratory abnormalities within 14 days of starting study drug: Absolute Neutrophil Count (ANC) \< 750 cells/μL (0.75 x 10\^9/L) Platelet count \< 50,000/μL (50x10\^9/L) Serum creatinine \> 2.5 mg/dL Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \> 3.0 x Upper Limit of Normal (ULN)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT00812968
Study Brief:
Protocol Section:
NCT00812968