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Recruiting NCT05509933

Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation

Phase III Interventional Engraftment Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Budesonide.
Who it may be relevant to
Registry conditions: Engraftment Syndrome. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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.

Interventions

  • Drug Budesonide
    budesonide starting day 5 after transplant

Primary outcome measures

  • non-infectious fever [Time frame: 30 days post stem cell transplant]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Henry Ford Health System — Detroit

Identifiers

NCT: NCT05509933 · 15795

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗