Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation

Henry Ford Health

Status and phase: Enrolling; Phase 3

Conditions: Engraftment Syndrome

Treatments: Drug: Budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT05509933

15795

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

110 participants in 2 patient groups

Budesonide

Experimental group

Treatment:

Drug: Budesonide

nothing

No Intervention group