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Pediatric GVHD Low Risk Steroid Taper Trial
NCT05090384 · View on ClinicalTrials.gov ↗
Study Summary
The standard treatment for acute graft-vs-host disease (GVHD) is to suppress the activity of the donor immune cells using steroid medications such as prednisone. Although most GVHD, especially in children, responds well to treatment, sometimes (around 1/3 of the time) there is either no response to steroids or the response does not last. In those cases, the GVHD can become dangerous and even life-threatening. Unfortunately, doctors cannot predict who will have a good response to treatment based on symptom severity or initial response to steroids. As a result, nearly all children who develop GVHD are treated with long courses of high dose steroids even though that means many patients receive more treatment than they probably need. Steroid treatment can cause short-term complications like infections, high blood sugar, high blood pressure, muscle weakness, depression, anxiety, and problems sleeping and long-term complications like bone damage, cataracts in the eyes, and decreased growth. The risk of these complications increases with higher doses of steroids and longer treatment. It is important to find ways to decrease the steroid treatment in patients who do not need long courses. The doctors conducting this research have developed a blood test (GVHD biomarkers) that predicts whether a patient will respond well to steroids. The study team found that children who have low GVHD biomarkers at the start of treatment and for the first two weeks of treatment have a very high response rate to steroids. In this study, the study team will monitor GVHD symptoms and biomarkers during treatment and taper steroids quickly in patients who have GVHD that is expected to respond very well to treatment. The study team will assess how many patients respond well to lower steroid dosing and what steroid complications develop. The study team will also use surveys to obtain the patient's own assessment of their quality of life (down to age 5 years).
Conditions Studied
Interventions
- DRUG Prednisone
Study Locations (11)
New York
- Icahn School of Medicine at Mount Sinai — New York
- Memorial Sloan Kettering Cancer Center — New York
California
- Children's Hospital of Los Angeles — Los Angeles
District of Columbia
- Children's National Hospital — Washington D.C.
Georgia
- Children's Healthcare of Atlanta — Atlanta
Massachusetts
- Boston Children's Hospital Dana Farber Cancer Institute — Boston
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
Tennessee
- Vanderbilt University Medical Center — Nashville
Texas
- Texas Children's Hospital, Baylor College of Medicine — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-10-20 |
| Est. Completion | 2026-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05090384
The ClinicalTrials.gov registry entry for NCT05090384 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is John Levine, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Adverse Effects appearing as the primary indexed condition, and to 1 intervention — of which Prednisone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05090384 reports 11 study locations spanning 10 distinct geographic areas — top geographies include New York, California, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05090384 about?
NCT05090384 is a clinical study titled "Pediatric GVHD Low Risk Steroid Taper Trial". The standard treatment for acute graft-vs-host disease (GVHD) is to suppress the activity of the donor immune cells using steroid medications such as prednisone. Although most GVHD, especially in children, responds well to treatment, sometimes (around 1/3 of the time) there is either no response to ...
What is the current status of trial NCT05090384?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2022-10-20. Estimated completion is 2026-03.
What conditions does trial NCT05090384 study?
This clinical trial studies the following conditions: Adverse Effects, Allogeneic Bone Marrow Transplantation, Acute Graft vs Host Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05090384?
The interventions under investigation include: Prednisone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05090384?
This trial is sponsored by John Levine, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05090384 being conducted?
This trial has 11 study locations across California, District of Columbia, Georgia, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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