NCT05509933

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
20mo left

Started Nov 2022

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Nov 2022Dec 2027

First Submitted

Initial submission to the registry

August 19, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 9, 2022

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

5.1 years

First QC Date

August 19, 2022

Last Update Submit

April 29, 2026

Conditions

Engraftment Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Budesonide

EXPERIMENTAL
Drug: Budesonide

nothing

NO INTERVENTION

Interventions

BudesonideDRUG

budesonide starting day 5 after transplant

Budesonide

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients enrolled in investigational clinical trials
  • Sct for non hematologic malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Interventions

Budesonide

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

shatha farhan

CONTACT

3137133910sfarhan1@hfhs.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 19, 2022

First Posted

August 22, 2022

Study Start

November 9, 2022

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations

US(1)