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

Phase 2

Withdrawn

• Conditions: Acute Myeloid Leukemia NOS
• Interventions: Drug: sargramostim GZ402664

• Registration Number: NCT02520102
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study First Submitted: 2015-08-07
• Study First Submitted QC: 2015-08-07
• Study First Posted: 2015-08-11
• Study Start: 2017-02
• Primary Completion: 2017-02-28
• Study Completion: 2017-02-28
• Status Verified: 2017-03
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sargramostim	sargramostim GZ402664	Sargramostim is administered daily until the absolute neutrophil count (ANC) equals or exceeds 1500/mm\^3 for 3 consecutive measurements or up to 42 days post-induction chemotherapy.

Primary Outcome Measures

Name	Time	Method
Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)	6 months after 1st dose of sargramostim. If positive at month 6, this will be continued every 6 months until the values return to baseline or up to 24 months

Secondary Outcome Measures

Name	Time	Method
Assessment of antibodies (antibody detection and antibody titers)	6 months after 1st dose of sargramostim. If positive at month 6, this will be continued every 6 months until the values return to baseline up to 24 months
Assessment of immunoglobulin levels	6 months after 1st dose of sargramostim. If antibodies are positive at month 6, the level of immunoglubolins will be assesed every 6 months until the antibodies level return to baseline or up to 24 months
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