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Corticosteroid

Budesonide for Engraftment Syndrome After Stem Cell Transplant

Phase 3
Recruiting
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 hematological malignancies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post stem cell transplant
Awards & highlights

Study Summary

This trial tests if a drug can reduce fever after stem cell transplants, to help patients recover better.

Who is the study for?
This trial is for adults aged 18-80 who are set to undergo stem cell transplantation for blood cancers. It's not open to those getting transplants for non-blood cancers or anyone already in another clinical study.Check my eligibility
What is being tested?
The trial is testing if budesonide, started on day 5 after a transplant, can prevent engraftment fever in patients receiving their own (autologous) or donor (allogeneic) stem cells.See study design
What are the potential side effects?
Budesonide may cause side effects like irritation of the stomach lining, increased risk of infection, high blood sugar levels, and mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 80 years old and have been diagnosed with a blood cancer.
Select...
I am eligible for a stem cell transplant according to the BMT program's criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post stem cell transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post stem cell transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
non-infectious fever

Side effects data

From 2016 Phase 4 trial • 222 Patients • NCT02055352
9%
Nasopharyngitis
9%
Influenza
8%
Headache
7%
Dysphonia
6%
Urinary tract infection
6%
Arthralgia
5%
Back pain
2%
Chronic obstructive pulmonary disease
1%
Peripheral arterial occlusive disease
1%
Venous thrombosis limb
1%
Vascular insufficiency
1%
Acute myocardial infarction
1%
Cor pulmonale
1%
Nodal arrhythmia
1%
Pneumonia
1%
Hip fracture
1%
Hepatocellular carcinoma
1%
Acute pulmonary oedema
1%
Bradycardia
1%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fluticasone / Salmeterol (B)
Budesonide / Indacaterol (A)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BudesonideExperimental Treatment1 Intervention
Group II: nothingActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Budesonide
2017
Completed Phase 4
~13050

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
300 Previous Clinical Trials
2,100,017 Total Patients Enrolled

Media Library

Budesonide (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05509933 — Phase 3
Engraftment Syndrome Research Study Groups: nothing, Budesonide
Engraftment Syndrome Clinical Trial 2023: Budesonide Highlights & Side Effects. Trial Name: NCT05509933 — Phase 3
Budesonide (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05509933 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial open to those over the age of fifty?

"As stipulated by the study's regulations, people who are 18 or over can be enrolled and those under 80 may participate."

Answered by AI

What is the current enrollment of this experiment?

"Affirmative. The relevant information hosted on clinicaltrials.gov indicates that this experiment is currently seeking participants; the study was initially posted on November 9th 2022 and later amended with a minor edit to its details. Approximatively 110 people need to be recruited from one location for this trial."

Answered by AI

Has Budesonide received its stamp of approval from the FDA?

"Due to the presence of clinical data indicating efficacy and numerous reports validating safety, our team at Power have assigned Budesonide a score of 3 on their scale."

Answered by AI

Is enrollment for this research endeavor still available?

"Affirmative. Clinicaltrials.gov records show that this research is actively searching for participants, with an initial posting date of November 9th 2022 and a most recent update on the same day. A total of 110 subjects need to be enrolled from one medical facility."

Answered by AI

Is my eligibility sufficient to partake in this clinical research?

"This trial seeks to enroll 110 people, between the ages of 18 and 80 who have a particular syndrome. In order for participants to qualify, they must meet two conditions: (1) be diagnosed with a hematological cancer; and (2) fulfill Bone Marrow Transplant Program criteria established for managing said malignancies."

Answered by AI
~42 spots leftby Jan 2025