MedTrace Logo

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

NCT02520102 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-04-20

No results posted yet for this study

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.

Conditions

  • Acute Myeloid Leukemia NOS

Interventions

DRUG

sargramostim GZ402664

Pharmaceutical form: lyophilized powder in vial Route of administration: subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-28
Primary Completion
2017-02-28
Completion
2017-02-28
FDA Drug
Yes

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02520102 on ClinicalTrials.gov