Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation
ConditionEngraftment Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHenry Ford Health System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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
Disqualifiers
• Patients enrolled in investigational clinical trials
Sct for non hematologic malignancies
Trial design
Design model
Parallel
Treatments tested in this trial
Budesonide
Drugbudesonide starting day 5 after transplant
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: BudesonideExperimental treatment 1 intervention
Group B: nothingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 transplantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov