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Blood test could help kids avoid harmful steroid side effects after transplant

NCT ID NCT05090384

Disease control Sponsor: John Levine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a blood test (GVHD biomarkers) can help doctors safely reduce steroid doses in children with graft-versus-host disease (GVHD) after a bone marrow transplant. Fifty children with newly diagnosed GVHD received prednisone, and those with low biomarker levels and good clinical response had their steroids tapered quickly. The goal was to see if this approach could maintain treatment success while reducing short- and long-term steroid side effects like infections, bone damage, and growth problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Prednisone
What this could lead to
If successful, this approach could reduce steroid side effects in children with GVHD while maintaining treatment effectiveness.
What could go wrong
This is a small Phase 2 trial with only 50 participants, so results may not apply to all children. The biomarker test may not accurately predict who can safely taper steroids.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

50 people

The number who actually took part.

Started

Oct 2022

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Newly diagnosed GVHD that meets criteria for Minnesota standard risk (see section 9.0) except isolated skin rash \<25% body surface area without other manifestations. * Ann Arbor 1 GVHD by biomarkers * GVHD not previously treated systemically (topical therapies and non-absorbed steroids are allowed) * Any donor type, HLA-match, conditioning regimen is acceptable * Age 0-21 years at the time of screening * Signed and dated written informed consent obtained from patient or legal representative and assent from pediatric patients capable of providing assent Exclusion Criteria: * Patients treated for GVHD with \>0.5 mg/kg/day prednisone for any duration or any steroid treatment for GVHD for more than 2 days prior to screening. * Patients receiving corticosteroids \>0.1 mg/kg prednisone (or other steroid equivalent) for any indication within 7 days before the onset of acute GVHD except for adrenal insufficiency, premedication for transfusions/IV medications, or intermittent use for symptom control such as nausea/vomiting * Relapsed, progressing, or persistent malignancy or other condition (e.g., known declining donor chimerism) requiring withdrawal of systemic immune suppression or donor leukocyte infusion (DLI) * Patients with uncontrolled infection (i.e., progressive symptoms related to infection despite treatment, persistently positive microbiological cultures despite treatment, viral reactivations unresponsive to treatment, or any other evidence of severe infection) * A clinical presentation resembling de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment * Patients who are pregnant * Patients requiring mechanical ventilation or cardiac pressor support

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Conditions

The condition(s) this trial relates to.

acute graft versus host disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute graft VS host disease Adverse effects Allogeneic bone marrow transplantation

Contacts and locations

Locations

  • Boston Children's Hospital Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322, United States

  • Children's Hospital of Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's National Hospital

    Washington D.C., District of Columbia, 20010, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Medical College of Wisconsin / Children's Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Texas Children's Hospital, Baylor College of Medicine

    Houston, Texas, 77030, United States

  • The Hospital for Sick Children

    Toronto, Ontario, M5S, Canada

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37235, United States

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