Using budesonide to prevent engraftment syndrome after stem cell transplantation
Official title: Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation
Run by Henry Ford Health System · NCT05509933 · Data updated 2026-11-12
This study is testing if the medication budesonide can help prevent fever and other symptoms after stem cell transplants in patients with blood cancers.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Henry Ford Health System Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Status | Recruiting |
| Started | November 9, 2022 |
| Main results expected | December 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT05509933 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18-80 with a diagnosis of a hematological malignancy who are eligible for hematopoietic stem cell transplantation.
✕Probably not a fit
Patients with non-hematologic malignancies or those currently enrolled in other investigational clinical trials may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of budesonide prophylaxis starting on day 5 after hematopoietic cell transplantation in reducing the incidence of engraftment fever among patients. It focuses on both autologous and allogeneic stem cell transplant recipients diagnosed with hematological malignancies. The study is interventional and is currently in Phase 3, indicating a robust assessment of the treatment's efficacy and safety. Participants will be monitored for outcomes related to engraftment syndrome following their transplant procedures.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of engraftment fever, improving recovery and outcomes for transplant patients.
How similar studies have gone: While this specific approach may be novel, similar studies exploring prophylactic treatments for engraftment syndrome have shown promise in improving patient outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Patients 18-80 years of age with a diagnosis of a hematological malignancy * Meet the BMT program criteria to undergo hematopoietic stem cell transplantation for hematologi malignancies Exclusion Criteria: * • Patients enrolled in investigational clinical trials * Sct for non hematologic malignancies
Where it's running
-
Henry Ford Health System
Detroit, Michigan, United States Recruiting
Study contacts
- Study coordinator: shatha farhan
- Email: sfarhan1@hfhs.org
- Phone: 3137133910
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.