Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia

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.

Timeline

Start

2017-02

Primary completion

2017-02-28

Completion

2017-02-28

Outcome

Outcome not reported

Stopped: “Company has fulfilled post-marketing requirements”

Drugs

Indications