Trials / Recruiting
RecruitingNCT05787574
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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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"
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Emapalumab | Emapalumab on Days -22 (22 days before the day of the stem cell transplant), -15, -8, and -1. |
| DRUG | Fludarabine and Dexamethasone | Fludarabine and dexamethasone for 5 days in a row on Days -22 through -18. |
| PROCEDURE | Stem Cell Transplant | Participants in both groups will receive their standard-of-care stem cell transplant on Day 0. |
Timeline
- Start date
- 2023-03-15
- Primary completion
- 2027-03-01
- Completion
- 2027-03-01
- First posted
- 2023-03-28
- Last updated
- 2025-10-29
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05787574. Inclusion in this directory is not an endorsement.