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 @ 3:49 AM
Ignite Modification Date:
2025-12-25 @ 3:49 AM
NCT ID:
NCT02520102
Eligibility Criteria:
Inclusion criteria :
* Able to provide informed consent.
* Newly diagnosed acute myeloid leukemia (AML) to be treated with standard of care induction chemotherapy as per local policy.
* Patients 55 to 70 years of age (inclusive).
* Negative serum pregnancy test within 30 days prior to receiving the first dose of induction chemotherapy in female participants who are \<2 years postmenopausal or who are of childbearing potential and have agreed to begin or continue using an adequate method of contraception.
Exclusion criteria:
* Prior treatment with sargramostim or any leukocyte growth factor (LGF) product.
* Prior myelodysplastic syndrome (MDS).
* Known central nervous system (CNS) leukemic involvement diagnosed by cytologic findings in cerebrospinal fluid and/or by computed tomography (CT) or magnetic resonance imaging (MRI).
* Out of range (\>2x normal) laboratory values.
* Clinically important medical conditions unrelated to AML as determined by the Investigator.
* Eastern Cooperative Oncology Group (ECOG) performance status \>2.
* Bone marrow blasts ≥5% on marrow examination following induction or reinduction chemotherapy.
* History of allergy to yeast products, recombinant human granulocyte/macrophage-colony-stimulating factor, or any component of sargramostim.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
70 Years
Study:
NCT02520102
Study Brief:
Protocol Section:
NCT02520102