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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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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

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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~1350

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor
348 Previous Clinical Trials
5,227,949 Total Patients Enrolled
3 Trials studying Sepsis
9,700 Patients Enrolled for Sepsis
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 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 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
~17 spots leftby Nov 2025
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