Budesonide Prophylaxis for Engraftment Syndrome After Hem... | NCT05509933

Studies
Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation

NCT05509933

Sponsor

Henry Ford Health System

Status

Recruiting

Last Update Posted

May 1, 2026Actual

Enrollment

110Estimated

Phase

Phase 3

Conditions

Engraftment Syndrome

Interventions

Budesonide

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 9, 2022Actual

Primary Completion Date

Dec 30, 2027Estimated

Completion Date

Dec 30, 2027Estimated

First Submitted Date

Aug 19, 2022

First Submission Date that Met QC Criteria

Aug 19, 2022

First Posted Date

Aug 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2026

Last Update Posted Date

May 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Budesonide	Experimental		Drug: Budesonide
nothing	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Budesonide	Drug	budesonide starting day 5 after transplant	Budesonide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
shatha farhan	Contact	3137133910		sfarhan1@hfhs.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Henry Ford Health System	Recruiting	Detroit	Michigan	48202	United States

Intervention Browse Module

MeSH Terms

ID	Term
D019819	Budesonide

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided