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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Lead sponsor: Memorial Sloan Kettering Cancer Center to Joseph Ovedv16 Show 5 more changesShow less
    • Study sites: 12 to 13
    • Interventions: Emapalumab (Drug), Fludarabine and Dexamethasone (Drug), Stem Cell Transplant (Procedure) to Allogeneic hematopoietic stem cell transplant (allo-HCT) (Procedure), Emapalumab (Drug), Fludarabine and Dexamethasone (Drug)
    • Secondary endpoints: 1 to 18
    • Study description expanded, about 240 words
    • Eligibility criteria expanded, about 2 words
  2. Re-verified, no change to tracked fieldsv15
  3. Site contacts updated at 7 of 12 sitesv14
  4. Study sites: 11 to 12v13
  5. Re-verified, no change to tracked fieldsv12
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 10 to 11v11
  2. Re-verified, no change to tracked fieldsv10
  3. Site details revised at 1 of 10 sitesv9
  4. Site details revised at 1 of 10 sitesv8
  5. Site details revised at 1 of 10 sitesv7
  6. Study sites: 7 to 10v6
  7. 3 versions Re-verified since May 31, 2024, no change to tracked fieldsv3-v5
  8. Eligibility criteria expanded, about 4 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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"
Trial Details
NCT Number NCT05787574
Lead Sponsor Joseph Oved
Collaborators: Sobi, Inc.
Conditions
(from sponsor)		 Primary Immune Regulatory Disorder, Autoimmune Lymphoproliferative, Immune System Diseases
Related terms Immune System Diseases
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov