Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT02520102
Status:
WITHDRAWN
Last Update Posted:
2017-04-20
First Post:
2015-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Phase II Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia
Status:
WITHDRAWN
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company has fulfilled post-marketing requirements
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1148-1183 | OTHER | UTN | View |