Back to resultsBudesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation
Primary Purpose
Engraftment Syndrome
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Budesonide
Sponsored by
About this trial
This is an interventional prevention trial for Engraftment Syndrome
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
Sites / Locations
- Henry Ford Health SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Budesonide
nothing
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05509933
First Posted
August 19, 2022
Last Updated
November 9, 2022
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT05509933
Brief Title
Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation
Official Title
Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2022 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Engraftment Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Budesonide
Arm Type
Experimental
Arm Title
nothing
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Description
budesonide starting day 5 after transplant
Primary Outcome Measure Information:
Title
non-infectious fever
Description
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
Time Frame
30 days post stem cell transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shatha farhan
Phone
3137133910
Email
sfarhan1@hfhs.org
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shatha farhan
Phone
313-916-5002
Email
sfarhan1@hfhs.org
12. IPD Sharing Statement
Learn more about this trial
Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation
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