Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation

Phase 3RecruitingNCT05509933

Henry Ford Health System110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

110

Conditions

Engraftment Syndrome

Interventions

BudesonideDRUG

budesonide starting day 5 after transplant

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Henry Ford Health System

Detroit, Michigan, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 30 days post stem cell transplant

Central Contacts

shatha farhan

CONTACT

3137133910 sfarhan1@hfhs.org

Data from ClinicalTrials.gov

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