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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT05237258
Eligibility Criteria:
Inclusion Criteria:
* Patient Inclusion Criteria
* Hospitalized patients (age ≥ 18 years) with high-risk AML defined as:
* Patients with new diagnosis ≥ 60 years of age
* An antecedent hematologic disorder
* Therapy related-disease
* Relapsed or primary refractory AML
* Within five business days of initiating therapy with either a) intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or a similar intensive regimen requiring prolonged hospitalization; or b) hypomethylating agents +/- additional agents or modification of this regimen on a clinical trial.
* Caregiver Inclusion Criteria
* Adult (≥18 years) relative or friend of a participating patient who the patient identifies as living with or has in-person contact with them at least twice per week.
Exclusion Criteria:
\- Patient Exclusion Criteria
* Patients with a diagnosis of acute promyelocytic leukemia (APML)
* Patients with AML receiving supportive care alone
* Patients with psychiatric or cognitive conditions which the treating clinicians believe prohibits informed consent or compliance with study procedures
* Patients seen by a palliative care clinician (MD, DO, APP) during two previous hospitalizations in the six months prior to enrollment
* Patients expected to be discharged within 2 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT05237258
Study Brief:
Protocol Section:
NCT05237258