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 @ 2:33 AM
Ignite Modification Date:
2025-12-25 @ 2:33 AM
NCT ID:
NCT01358734
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed acute myeloid leukemia (AML), AML with antecedent hematologic disorder or therapy-related AML
* Male or female subjects aged ≥ 65
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* White blood cell (WBC) count ≤ 10 x 10⁹/L at screening
Exclusion Criteria:
* Previous treatment with azacitidine, decitabine, cytarabine or lenalidomide
* Previous cytotoxic or biologic treatment of any kind for AML or prior use of targeted therapy agents.
* Suspected or proven acute promyelocytic leukemia
* Prior bone marrow or stem cell transplantation
* Candidate for allogeneic bone marrow or stem cell transplantation
* AML antecedent hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms
* Presence of malignant disease within the previous 12 months with exceptions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01358734
Study Brief:
Protocol Section:
NCT01358734