Engraftment SyndromePhase 3NCT05509933
Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation
A Phase 3 study testing Budesonide in people with Engraftment Syndrome, run by Henry Ford Health System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Engraftment Syndrome
- What is being tested?
- Budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2022to 30 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • Patients enrolled in investigational clinical trials
- Sct for non hematologic malignancies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
shatha farhan, 313-916-5002, sfarhan1@hfhs.org
About this study
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.
- Conditions
- Engraftment Syndrome
- Being tested
- Budesonide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
budesonide starting day 5 after transplant
| Study group | Role | What they receive |
|---|---|---|
| Budesonide | Experimental | Not described Receives: Drug: Budesonide |
| nothing | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days post stem cell transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start9 Nov 2022
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Engraftment SyndromeStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shatha Farhan, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509933
- Sponsor's protocol ID
- 15795
- Status last verified
- Apr 2026
- First submitted
- 19 Aug 2022
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT05509933
- Acronym / sponsor ID
- 15795
- Conditions
- Engraftment Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide | Experimental | Drug: Budesonide |
| nothing | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • Patients 18-80 years of age with a diagnosis of a hematological malignancy
Key exclusion criteria (2 listed)
- • Patients enrolled in investigational clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonidebudesonide starting day 5 after transplant | Drug | Budesonide |
Primary outcome
non-infectious fever
Time frame: 30 days post stem cell transplant
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Safety Study of Zinc Finger Nuclease CCR5-modified Hematopoietic Stem/Progenitor Cells in HIV-1 Infected Patients
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RecruitingPhase 1/2
Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome
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Active, not recruitingPhase 2
A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant
AML, NHL
Recruiting
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
Hematologic Disorders, Hemoglobinopathies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide in people with Engraftment Syndrome, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shatha farhan (3137133910, sfarhan1@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
non-infectious fever (time frame: 30 days post stem cell transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.