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Cytokine

GM-CSF for MODS (GRACE Trial)

Phase 4
Waitlist Available
Led By Mark W Hall, MD
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up subjects will be screened for immunoparalysis throughout their first three weeks of sepsis-induced mods
Awards & highlights

Summary

This trial will help to establish the dose and route of GM-CSF delivery that is most efficacious in reversing sepsis-induced immunoparalysis in children.

Eligible Conditions
  • Sepsis-induced Multiple Organ Dysfunction Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~subjects will be screened for immunoparalysis throughout their first three weeks of sepsis-induced mods
This trial's timeline: 3 weeks for screening, Varies for treatment, and subjects will be screened for immunoparalysis throughout their first three weeks of sepsis-induced mods for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
TNF-alpha response

Trial Design

4Treatment groups
Experimental Treatment
Group I: SQ GM-CSF 250 mcg/m2/doseExperimental Treatment1 Intervention
If the SQ 125 mcg/m2/dose arm is not successful in a cohort of subjects (or if the IV dose had to be escalated to 250 mcg/m2/dose), we will transition to 250 mcg/m2/day via the SQ route for 7 consecutive days in a subsequent cohort.
Group II: SQ GM-CSF 125 mcg/m2/doseExperimental Treatment1 Intervention
Subjects in this arm who demonstrate immunoparalysis will receive GM-CSF by the subcutaneous (SQ) route at a dose of 125 mcg/m2/day for 7 consecutive days.
Group III: IV GM-CSF 250 mcg/m2/doseExperimental Treatment1 Intervention
If the IV 125 mcg/m2/dose arm is not successful in the first cohort of subjects, we will transition to 250 mcg/m2/day via the IV route for 7 consecutive days in a subsequent cohort.
Group IV: IV GM-CSF 125 mcg/m2/doseExperimental Treatment1 Intervention
Subjects in this arm who demonstrate immunoparalysis will receive GM-CSF by the intravenous (IV) route at a dose of 125 mcg/m2/day for 7 consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GM-CSF
2014
Completed Phase 4
~1340

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor
347 Previous Clinical Trials
5,229,106 Total Patients Enrolled
Mark W Hall, MDPrincipal InvestigatorNationwide Children's Hospital
1 Previous Clinical Trials
108 Total Patients Enrolled

Media Library

GM-CSF (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT03769844 — Phase 4
Sepsis-induced Multiple Organ Dysfunction Syndrome Research Study Groups: SQ GM-CSF 125 mcg/m2/dose, SQ GM-CSF 250 mcg/m2/dose, IV GM-CSF 125 mcg/m2/dose, IV GM-CSF 250 mcg/m2/dose
Sepsis-induced Multiple Organ Dysfunction Syndrome Clinical Trial 2023: GM-CSF Highlights & Side Effects. Trial Name: NCT03769844 — Phase 4
GM-CSF (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03769844 — Phase 4
~18 spots leftby Sep 2025
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