Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05509933

Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Engraftment Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location status: Recruiting

Location contact

shatha farhan

CONTACT

[email protected]

313-916-5002

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide

Drug

budesonide starting day 5 after transplant

Primary outcomes

  1. non-infectious fever

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

shatha farhan

CONTACT

[email protected]

3137133910

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 22, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.