Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation

Engraftment Syndrome Clinical Trial

Official title:

Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05509933
• Other study ID #: 15795
• Status: Recruiting
• Phase: Phase 3
• Start date: November 9, 2022
• Est. completion date: December 30, 2026

Study information

• Verified date: April 2024
• Source: Henry Ford Health System
• Contact: shatha farhan
• Phone: 3137133910
• Email: sfarhan1[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if budesonide prophylaxis starting day 5 after transplant reduces engraftment fever in autologous and allogeneic stem cell transplant recipients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 30, 2026
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Engraftment Syndrome
• Syndrome

Intervention

Drug:
• Budesonide
budesonide starting day 5 after transplant

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	non-infectious fever	non infectious fever defined as fever without identified infection that occurs up to 3 days prior and 10 days after the day of engraftment in patients on budesonide prophylaxis compared to patients who will not receive prophylaxis	30 days post stem cell transplant