Budesonide Prophylaxis for Engraftment Syndrome After Autologous Hematopoietic Cell Transplantation

• Sponsor: Henry Ford Health System (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05509933
• Collaborator: (none)
• Enrollment: 110
• Arms: 2
• Anticipated Duration (Months): 39.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Engraftment Syndrome	Drug: Budesonide	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Budesonide Prophylaxis for Engraftment Syndrome After Autologous Hematopoietic Cell Transplantation
• Anticipated Study Start Date: Sep 23, 2022
• Anticipated Primary Completion Date: Dec 30, 2023
• Anticipated Study Completion Date: Dec 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Budesonide	Drug: Budesonide; budesonide starting day 5 after transplant
No Intervention: nothing

Outcome Measures

Primary Outcome Measures

1. engraftment fever [30 days post stem cell transplant]

   Engraftment fever in patients on budesonide prophylaxis compared to patients who did not receive prophylaxis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Henry Ford Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shatha Farhan, MD, Henry Ford Health System
• ClinicalTrials.gov Identifier: NCT05509933
• Other Study ID Numbers: 15795
• First Posted: Aug 22, 2022
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Syndrome; Budesonide

Study Results

No Results Posted as of Aug 22, 2022