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NCT05787574 · ClinicalTrials.gov registry record · Phase 2
A Study of Treatment of Inflammation Before Stem Cell Transplant in People With a Primary Immune Regulatory Disorder (PIRD) and/or an Autoinflammatory Condition
A Phase 2 study of Immune System Diseases and Autoimmune Lymphoproliferative, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 12
- Study locations
NCT05787574: Recruiting Phase 2 study of Immune System Diseases and Autoimmune Lymphoproliferative, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05787574 is a Phase 2 study of Immune System Diseases and Autoimmune Lymphoproliferative that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 39 participants, below the 151-participant average among 18 other Immune System Diseases trials with a reported enrollment target (74% lower). The trial reports 12 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05787574, a Phase 2 study of Immune System Diseases and Autoimmune Lymphoproliferative, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 12
- Study locations
Study 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"
Primary Outcome
Engraftment is defined as the first of three days of absolute neutrophil count \>500,000/µL and the first of seven days of platelets \>20,000/µL in the absence of transfusional support.
Conditions Studied
Interventions
- DRUG Emapalumab
- DRUG Fludarabine and Dexamethasone
- PROCEDURE Stem Cell Transplant
Study Locations (12)
New York
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Rockville Centre
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
California
- University of California, San Francisco (Data collection only) - San Francisco
Georgia
- Children's Healthcare of Atlanta (Data Collection Only) - Atlanta
Pennsylvania
- Children's Hospital of Philadelphia (Data Collection Only) - Philadelphia
Texas
- Texas Children's Hospital (Data Collection) - Houston
Wisconsin
- Children's Hospital of Wisconsin (Data Collection Only) - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2023-03-15 |
| Est. Completion | 2027-03 |
| Phase | Phase 2 |
What NCT05787574 shows while recruiting
NCT05787574 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 151-participant average among 18 other Immune System Diseases trials with a reported enrollment target (74% lower).
The record links to 3 conditions, with Immune System Diseases appearing as the primary indexed condition, and to 3 interventions - of which Emapalumab is the first listed.
NCT05787574 lists 12 locations in 7 states (New York, New Jersey, California).
Frequently Asked Questions
What is clinical trial NCT05787574 about?
NCT05787574 is a clinical study titled "A Study of Treatment of Inflammation Before Stem Cell Transplant in People With a Primary Immune Regulatory Disorder (PIRD) and/or an Autoinflammatory Condition". 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 a...
What is the current status of trial NCT05787574?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2023-03-15. Estimated completion is 2027-03.
What conditions does trial NCT05787574 study?
This clinical trial studies the following conditions: Immune System Diseases, Autoimmune Lymphoproliferative, Primary Immune Regulatory Disorder.
What interventions are being tested in trial NCT05787574?
The interventions under investigation include: Emapalumab (DRUG), Fludarabine and Dexamethasone (DRUG), Stem Cell Transplant (PROCEDURE).
Who is sponsoring clinical trial NCT05787574?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05787574 being conducted?
This trial has 12 study locations across California, Georgia, New Jersey, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05787574's enrollment target sits among peer trials
39 11th of 18 higher than 8 of 18 other Immune System Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Immune System Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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