Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation

NCT ID: NCT05509933

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-09

Study Completion Date

2026-12-30

Brief Summary

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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

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Conditions

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Engraftment Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Budesonide

Group Type EXPERIMENTAL

Budesonide

Intervention Type DRUG

budesonide starting day 5 after transplant

nothing

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Budesonide

budesonide starting day 5 after transplant

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Shatha Farhan

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Henry Ford Health System

Detroit, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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shatha farhan

Role: CONTACT

3137133910

Facility Contacts

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shatha farhan

Role: primary

313-916-5002

Other Identifiers

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15795

Identifier Type: -

Identifier Source: org_study_id

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