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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT00528333
Eligibility Criteria:
Inclusion Criteria:
* Untreated AML that occurred de novo, after prior exposure to chemotherapy for a separate malignancy, or evolved from an antecedent hematologic disorder.
* After being informed of the potential benefits and risks of available treatment options, patients must have declined intensive chemotherapy for AML.
* At least 20% blasts in blood or marrow.
* Must have a minimum of 50% leukemic blasts that express CD33.
* ECOG performance status score of 0 to 2.
* WBC less than 30,000/µL
Exclusion Criteria:
* No known diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia.
* No other active systemic malignancies treated with chemotherapy within the last 12 months.
* Must not have received previous chemotherapy (except hydroxyurea) for AML.
* Must not have significantly abnormal kidney or liver disease.
* Must not have known human immunodeficiency virus (HIV).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT00528333
Study Brief:
Protocol Section:
NCT00528333