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 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT00088218
Eligibility Criteria:
Inclusion Criteria:
* Previously untreated AML and high-risk MDS ( \> 10% blasts, or International Prognostic Scoring System (IPSS) intermediate-2). Prior therapy with hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or "targeted" therapies are allowed.
* Age \> 60 years.
* Eastern Cooperative Oncology Group (ECOG) performance status \</= 2.
* Sign a written informed consent form.
* Adequate liver function (total bilirubin \< 2mg/dL,serum glutamic pyruvic transaminase (SGPT) or Serum glutamic oxaloacetic transaminase (SGOT) \< x 4 upper limit of normal (ULN)) and renal function (serum creatinine \< 2mg/dL).
Exclusion Criteria:
* Patients with \>= New York Heart Association (NYHA) grade 3 heart disease as assessed by history and/or physical examination.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT00088218
Study Brief:
Protocol Section:
NCT00088218