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NCT05090384 · ClinicalTrials.gov registry record · Phase 2
Pediatric GVHD Low Risk Steroid Taper Trial
A Phase 2 study of Adverse Effects and Allogeneic Bone Marrow Transplantation, sponsored by John Levine.
- Active
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 11
- Study locations
NCT05090384: Active Phase 2 study of Adverse Effects and Allogeneic Bone Marrow Transplantation, sponsored by John Levine.
NCT05090384 is a Phase 2 study of Adverse Effects and Allogeneic Bone Marrow Transplantation that is active but no longer recruiting, run by John Levine. The registered enrollment target is 50 participants, below the 66-participant average among 3 other Adverse Effects trials with a reported enrollment target (24% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05090384, a Phase 2 study of Adverse Effects and Allogeneic Bone Marrow Transplantation, is active but no longer recruiting, sponsored by John Levine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 11
- Study locations
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).
Primary Outcome
Number of participants who were responders. Responders are patients with low-risk GVHD (Minnesota standard risk/Ann Arbor 1) who are in CR, VGPR or PR on day 28 and whose cumulative prednisone (or other steroid equivalent) exposure during the first four weeks of treatment is ≤13.5 mg/kg and who have had no intervening additional GVHD therapy for those in CR or VGPR. Complete Response (CR): All evaluable organs (skin, liver, GI tract) stage 0. Very Good Partial Response (VGPR): Any response that
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 |
What the registry record for NCT05090384 still lists
NCT05090384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 66-participant average among 3 other Adverse Effects trials with a reported enrollment target (24% lower).
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.
NCT05090384 lists 11 locations in 10 states (New York, California, District of Columbia).
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.
What interventions are being tested in trial NCT05090384?
The interventions under investigation include: Prednisone (DRUG).
Who is sponsoring clinical trial NCT05090384?
This trial is sponsored by John Levine, which has 5 total clinical trials registered on ClinicalTrials.gov.
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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