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

• Status: Withdrawn
• Trial end date: 2017-02-28

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.

• Phase: Phase 2

Details

• Lead Sponsor: Sanofi
• Treatments: Sargramostim