Trial · NCT05787574
A Study of Treatment of Inflammation Before Stem Cell Transplant in People With a Primary Immune Regulatory Disorder (PIRD) and/or an Autoinflammatory Condition
NCT05787574, Phase 2, Recruiting, Joseph Oved
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Treatment of Inflammation Before Stem Cell Transplant in People With a Primary Immune Regulatory Disorder (PIRD) and/or an Autoinflammatory Condition. Trials, record NCT05787574. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05787574
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Treatment of Inflammation Before Stem Cell Transplant in People With a Primary Immune Regulatory Disorder (PIRD) and/or an Autoinflammatory Condition
- NCT number
- NCT05787574
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 39 participants, estimated
- Lead sponsor
- Joseph Oved
- Conditions
- Primary Immune Regulatory Disorder, Autoimmune Lymphoproliferative, Immune System Diseases
- Interventions
- Emapalumab, Fludarabine and Dexamethasone, Allogeneic hematopoietic stem cell transplant (allo-HCT)
- First posted
- 2023-03-28
- Last updated
- 2026-06-02
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Engraftment | Day 100 post-alloHCT | 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. |
| Secondary | Overall Survival (OS) | 1 year | Overall Survival (OS) is defined as the duration of time between allo-HCT and death due to any cause. |
| Secondary | Event Free Survival (EFS) | Up to 2 years post-alloHCT | Event-Free Survival (EFS) is the length of time from the start of a treatment or study until a patient experiences a defined negative "event" (such as disease recurrence, progression, or death). |
| Secondary | Non-Relapse Mortality (TRM) | 1 year | Participants who die for any reason after disease recurrence are considered to have experienced disease related mortality, and will be counted as competing events. Patients alive will be censored at the day of last follow up. |
| Secondary | GVHD free/relapse free survival (GRFS) | 1 year | Duration of time between transplantation and development of grade III-IV GVHD, chronic GVHD requiring systemic therapy, disease relapse, or death, whichever occurs first. |
| Secondary | Chronic graft vs host disease/relapse free survival (CRFS) | 1 year | Duration of time between transplantation and development of moderate or severe chronic GVHD (NIH consensus criteria), or death, whichever occurs first. |
| Secondary | All-cause mortality at 1 & 2 years | 1 year and 2 years post-alloHCT | |
| Secondary | Incidence of viral reactivations | 1 year | Incidence of viral reactivations including: Cytomegalovirus (CMV), Adenovirus, Epstein-Barr Virus (EBV), Human Herpes-6 (HHV6), BK-virus defined as viral reactivations necessitating use of anti-viral treatment. |
| Secondary | Incidence of Acute graft versus host disease (GVHD) at Day 100, 180, and 1-year follow-up | Day 100, 180, and 1 year post-alloHCT | |
| Secondary | Incidence of Chronic GVHD at Day 180 and 1-year follow-up | Day 180 and 1 year post-alloHCT |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD007829 | Phase 2 Bridging Pre-transplant Inflammatory Dampening for Primary Immune Regulatory Disorders (BRIDGE Trial) | OVED, JOSEPH H | SLOAN-KETTERING INST CAN RESEARCH | FOOD AND DRUG ADMINISTRATION | 2023 to 2024 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05787574
GET https://conductscience.org/api/trials/v1/NCT05787574/registered