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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT01211457
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed AML based on WHO classification (Part 1) or previously treated AML or MDS (Part 2)
* Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator (Part 1); age 18 years or older (Part 2)
* ECOG performance status 0-2
* Adequate renal function
* Adequate liver function
* Able to swallow capsules
* Ability to understand and willingness to sign the informed consent form
Exclusion Criteria:
* AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
* Known central nervous system (CNS) involvement by leukemia
* Uncontrolled intercurrent illness including
* Known hypersensitivity to decitabine (Part 1) or venetoclax (Part 2)
* Known to be HIV-positive
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01211457
Study Brief:
Protocol Section:
NCT01211457