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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

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

Primary outcome measures

Engraftment

Secondary outcome measures

Determine Overall Survival (OS)

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

Emapalumab

2014

Completed Phase 3

~110

Stem Cell Transplant

2007

Completed Phase 3

~1350

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,859 Total Patients Enrolled

Sobi, Inc.Industry Sponsor

12 Previous Clinical Trials

588 Total Patients Enrolled

Joseph Oved, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05787574 — Phase 2

Immune System Disorders Research Study Groups: Group A: Emapalumab (for isolated Interferongamma mediated disease), Group B: Fludarabine and Dexamethasone (for generalized autoinflammation)

Immune System 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

Frequently Asked Questions

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

What potential risks are associated with the administration of Emapalumab for isolated Interferongamma mediated disease in Group A?

"By Power's standards, the safety of Group A: Emapalumab (for isolated Interferongamma mediated disease) ranks a 2 due to existing data in favour of its security but no documented efficacy."

Answered by AI

Is this medical exploration currently accessible to individuals seeking treatment?

"Affirmative. According to clinicaltrials.gov, this medical experiment initiated on March 15th 2023 and is still enrolling participants; 39 patients will be needed from 7 different healthcare facilities."

Answered by AI

How many participants is this trial recruiting?

"Affirmative. According to clinicaltrials.gov, this research project commenced on March 15th 2021 and is now actively seeking participants. 39 individuals are required from 7 distinct sites."

Answered by AI

In what geographic areas are the trials of this experiment being conducted?

"There are 7 sites active in this clinical trial, including Memorial Sloan Kettering Monmouth (Limited Protocol Activities) located in Middletown, New jersey and Memorial Sloan Kettering Bergen (Limited Protocol Activities) situated in Montvale. In addition to these two, the study is also being conducted at Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities). The other 4 locations remain undisclosed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Treatment of Inflammation Before Stem Cell Transplant in People With a Primary Immune Regulatory Disorder (PIRD) and/or an Autoinflammatory Condition

2023. "A Study of Treatment of Inflammation Before Stem Cell Transplant in People With a Primary Immune Regulatory Disorder (PIRD) and/or an Autoinflammatory Condition". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05787574.

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