Using budesonide to prevent engraftment syndrome after stem cell transplantation
Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation
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 |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Henry Ford Health System Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT05509933 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with non-hematologic malignancies or those currently enrolled in other investigational clinical trials may not benefit from this study.
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 performed: While this specific approach may be novel, similar studies exploring prophylactic treatments for engraftment syndrome have shown promise in improving patient outcomes.
Eligibility criteria
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 this trial is running
Detroit, Michigan
- Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: shatha farhan
- Email: sfarhan1@hfhs.org
- Phone: 3137133910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.