Acute Myeloid Leukemia NOS
Conditions
Brief summary
Primary Objective: Measure the proportion of patients who develop binding and neutralizing antibodies in the blood after treatment with sargramostim following induction/reinduction chemotherapy. Secondary Objectives: * Assess the time after treatment at which the antibodies develop and the level of antibodies is measured after the first dose. * Measure the levels of immunoglobulin protein. * Assess the impact of any immune response on safety and the duration of low white blood cell count.
Detailed description
The total study duration for a participant is up to 6 months from 1st dose of sargramostim or until the antibodies level return to baseline or up to 24 months if antibodies test is positive at month 6.
Interventions
Pharmaceutical form: lyophilized powder in vial Route of administration: subcutaneous
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies) | 1 month after 1st dose of sargramostim |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of antibodies (antibody detection and antibody titers) | 1 month after 1st dose of sargramostim |
| Assessment of immunoglobulin levels | 1 month after 1st dose of sargramostim |
| Proportion of patients with adverse events | Up to 24 months |
| Duration of neutropenia (time from initiation of sargramostim to recovery of ANC to ≥1500/mm^3) | Up to 42 days after first day of sargramostim administration |
Outcome results
None listed