RecruitingPhase 2NCT05787574

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

Phase 2 Study Bridging Pre-Transplant Inflammatory Dampening for Primary Immune Regulatory Disorders (BRIDGE Trial)


Sponsor

Joseph Oved

Enrollment

39 participants

Start Date

Mar 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The researchers are doing this study to find out whether emapalumab or a combination of fludarabine and dexamethasone are effective in preparing people with a primary immune regulatory disorder (PIRD) and/or an autoinflammatory condition to receive a stem cell transplant. The researchers will look at how well the study treatments reduce inflammation and aid in the engraftment process (the process of donated stem cells traveling to the bone marrow, where they begin to make new immune cells. "Funding Source - FDA OOPD"


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Allogeneic hematopoietic stem cell transplant (allo-HCT), a drug called Emapalumab, and others for people with autoimmune lymphoproliferative, immune system diseases, and other related conditions. The study is currently recruiting participants at 13 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmapalumab

Emapalumab on Days -22 (22 days before the day of the stem cell transplant), -15, -8, and -1.

DRUGFludarabine and Dexamethasone

Fludarabine and dexamethasone for 5 days in a row on Days -22 through -18.

PROCEDUREAllogeneic hematopoietic stem cell transplant (allo-HCT)

Participants in both groups will receive their standard-of-care stem cell transplant on Day 0.


Locations(13)

University of California, San Francisco

San Francisco, California, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Rockville Centre, New York, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Texas Children's Hospital

Houston, Texas, United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05787574


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