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Corticosteroid

Pre-Transplant Inflammation Treatment for Immune System Disorders

Phase 2
Recruiting
Led By Joseph Oved, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will study if emapalumab or a combo of fludarabine & dexamethasone can reduce inflammation & help stem cell transplants work for people with PIRD & autoinflammatory conditions.

Who is the study for?
This trial is for people with a primary immune regulatory disorder (PIRD) and/or an autoinflammatory condition who need a stem cell transplant. They should have good organ function, be able to handle cytoreduction, and not have had previous transplants. Pregnant or breastfeeding women, HIV/HTLV-positive individuals, and those unwilling to use contraception are excluded.
What is being tested?
The study tests if emapalumab alone or in combination with fludarabine and dexamethasone can reduce inflammation effectively before a stem cell transplant in patients with PIRD/autoinflammatory conditions. It aims to improve the engraftment success of the transplant.
What are the potential side effects?
Potential side effects may include reactions related to immune suppression such as increased risk of infection, liver enzyme changes, possible impact on heart or kidney function due to medication toxicity, and general side effects like nausea from chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Engraftment
Secondary study objectives
Determine Overall Survival (OS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group B: Fludarabine and Dexamethasone (for generalized autoinflammation)Experimental Treatment2 Interventions
Participants in this group will receive fludarabine and dexamethasone for 5 days in a row on Days -22 through -18.
Group II: Group A: Emapalumab (for isolated Interferongamma mediated disease)Experimental Treatment2 Interventions
Participants in this group will receive emapalumab on Days -22 (22 days before the day of the stem cell transplant), -15, -8, and -1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stem Cell Transplant
2007
Completed Phase 3
~1350
Emapalumab
2014
Completed Phase 3
~110

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,320 Total Patients Enrolled
Sobi, Inc.Industry Sponsor
13 Previous Clinical Trials
987 Total Patients Enrolled
Joseph Oved, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
55 Total Patients Enrolled

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05787574 — Phase 2
Immune Disorders Research Study Groups: Group A: Emapalumab (for isolated Interferongamma mediated disease), Group B: Fludarabine and Dexamethasone (for generalized autoinflammation)
Immune Disorders Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT05787574 — Phase 2
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05787574 — Phase 2
~22 spots leftby Mar 2027
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