Acute Myeloid Leukemia NOS Clinical Trial
Official title:
A Phase II Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia
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.
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. ;