Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT05509933
Phase
PHASE3
Status
Recruiting

Conditions

  • Engraftment Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Budesonide — DRUG
    budesonide starting day 5 after transplant

Study Details

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.

Key Dates

Start date
Nov 9, 2022
Status verified
Apr 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Budesonide
  • No Intervention: nothing

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford Health SystemDetroitMichigan48202
shatha farhan
313-916-5002

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