NCT02520102

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 55 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia NOS

Interventions

Type	Name	Description
DRUG	sargramostim GZ402664	Pharmaceutical form: lyophilized powder in vial Route of administration: subcutaneous

Timeline

• Start date: 2017-02-01
• Primary completion: 2017-02-28
• Completion: 2017-02-28
• First posted: 2015-08-11
• Last updated: 2017-04-20

Regulatory

• FDA-regulated drug study