Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05509933

Enrollment

110

Registered

2022-08-22

Start date

2022-11-09

Completion date

2027-12-30

Last updated

2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Engraftment Syndrome

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.

Interventions

DRUGBudesonide

budesonide starting day 5 after transplant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
non-infectious fever	30 days post stem cell transplant	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

Countries

United States

Contacts

CONTACTshatha farhan

sfarhan1@hfhs.org3137133910

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026