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 @ 2:41 PM
Ignite Modification Date:
2025-12-24 @ 2:41 PM
NCT ID:
NCT00631059
Eligibility Criteria:
Inclusion Criteria:
Newly Diagnosed Subjects
* The subject is male or female, aged 18 years of age or older
* The subject has a diagnosis of acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML); the subject must have a pathology-confirmed diagnosis
* The subject must have a pathology-confirmed diagnosis
* Acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML) is defined as having \>25% blasts in the bone marrow and/or peripheral blood
* The subject has not received any chemotherapy or treatment for their acute leukemia prior to the initial study visit
* The subject is able and willing to provide written informed consent
* The subject is able to understand the study and cooperate with all study instructions
Relapsed Subjects
* The subject is male or female, aged 18 years of age or older
* The subject has a diagnosis of relapsed acute lymphocytic leukemia (ALL) or relapsed acute myelogenous leukemia (AML)
* The subject must have a pathology-confirmed diagnosis
* Acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML) is defined as having ≥ 25% blasts in the bone marrow and/or peripheral blood
* The subject has received one or more of the pre-identified chemotherapeutic agents for treatment of their initial acute leukemia diagnosis
* The subject has not received any systemic chemotherapy or treatment for their relapsed acute leukemia
* Receipt of intrathecal chemotherapy will be permissible
* The subject is able and willing to provide written informed consent
* The subject is able to understand the study and cooperate with all study instructions
Exclusion Criteria:
* The subject has an uncontrolled serious medical or psychiatric illness that, in the opinion of the investigator, would compromise the subject's safety or collection of data
* The subject received treatment with an investigational drug within two weeks of the initial or subsequent study visits
* Subjects under the age of 18
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00631059
Study Brief:
Protocol Section:
NCT00631059