Recruiting
Phase 3

Budesonide

Sponsor:

Henry Ford Health System

Code:

NCT05509933

Conditions

Engraftment Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Budesonide

Study Details

Brief 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.

Conditions

Engraftment Syndrome

Study ID

NCT05509933

Start date

Nov 9, 2022

Status verified date

Apr, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Budesonide

no intervention: nothing

Interventions

Budesonide

budesonide starting day 5 after transplant

Primary outcome measure

  • non-infectious fever [ Time Frame: 30 days post stem cell transplant ]

Central Contacts and Locations

Central contacts

shatha farhan

3137133910sfarhan1@hfhs.org

Locations

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

shatha farhan

313-916-5002sfarhan1@hfhs.org

More Information

Sponsor

Henry Ford Health System

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-05-01.