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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

GRACE 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-induced Multiple Organ Dysfunction Syndrome

GRACE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ subjects will be screened for immunoparalysis throughout their first three weeks of sepsis-induced mods

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

TNF-alpha response

GRACE 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor

340 Previous Clinical Trials

5,220,353 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment into this experiment currently available?

"This research project is no longer enrolling patients, as per clinicaltrials.gov's information regarding this trial which was posted on December 5th 2018 and lastly updated February 24th 2022; nevertheless, there are 212 other ongoing studies currently searching for participants."

Answered by AI

How many participants have been accepted to participate in this research endeavor?

"This clinical trial, which was originally posted on December 5th 2018 and last modified on February 24th 2022, is no longer recruiting participants. If you're searching for alternative studies to join, there are currently 169 trials enrolling people with toxemia and 43 seeking patients who require GM-CSF treatment."

Answered by AI

What conditions does granulocyte-macrophage colony stimulating factor (GM-CSF) typically address?

"GM-CSF is commonly used to treat severe infections, as well as multiple cancers - including lymphoma, hodgkins disease and leukemia. It can also be employed in bone marrow transplant procedures."

Answered by AI

Are there any precedents of trials conducted with GM-CSF?

"In 2001, the Fred Hutchinson Cancer Research Centre/University of Washington Cancer Consortium launched an investigation into GM-CSF. Since then, 172 studies have been completed and 43 are now in progress; many of these trials occur within Los Angeles County."

Answered by AI

Has regulatory approval been given for the use of GM-CSF?

"Our experts at Power have assigned GM-CSF a score of 3 due to its Phase 4 status, which indicates this medication has achieved full FDA approval."

Answered by AI

How many hospitals and medical facilities are currently conducting this research?

"The current clinical trial is administered from UCLA Mattel Children's Hospital in Los Angeles, Benioff Children's Hospital/UCSF in San Francisco, Ohio and Nationwide Children’s Hospitals situated at the City of Columbus. Additionally, 8 other locations are partaking in this research initiative."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS Study

Mark Hall 2018. "GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03769844.

All > Sepsis