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New hope for transplant patients: drug combo may tame deadly immune attack

NCT ID NCT06936566

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called ruxolitinib for treating acute graft-versus-host disease (GVHD), a serious condition where donor cells attack the patient's body after a bone marrow transplant. About 98 adults with moderate to severe GVHD will receive either ruxolitinib alone or with standard steroids, depending on their risk level. The goal is to see if ruxolitinib can improve response and reduce the need for high-dose steroids, which have harsh side effects.

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

About 98 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

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

18 years and older

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: * Standard risk cohort: Minnesota standard risk GVHD (except patients with grade I \[\<50% BSA rash\]) * High risk cohort: Minnesota high risk GVHD 3 GVHD that developed after DLI for mixed chimerism or poor graft function is allowed * No prior systemic acute GVHD treatment. Topical or non-absorbed steroids are permitted. * All donor types, HLA-matches, conditioning regimens, or GVHD prophylaxis strategies are acceptable * ≥18 years of age * Standard risk cohort: Hematopoietic engraftment with absolute neutrophil count (ANC) ≥ 1000/μL and platelet count ≥20,000. Use of growth factor supplementation and transfusions to maintain adequate hematologic parameters are allowed. * High risk cohort: Hematopoietic engraftment with ANC ≥ 500/uL and platelet count ≥20,000. Use of growth factor supplementation and transfusions to maintain adequate hematologic parameters are allowed. Exclusion Criteria: * Systemic treatment with ruxolitinib or any other JAK inhibitor within 7 days of study entry * Prior use of ruxolitinib to treat GVHD at any time * Relapsed, progressing or persistent malignancy requiring withdrawal of systemic immunosuppression * Relapse prior to development of GVHD unless subsequently in remission for at least 3 months * GVHD that developed after DLI for relapse is not allowed without study PI or medical monitor approval * Uncontrolled infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis) * Severe organ dysfunction within 3 days of enrollment including requirement for dialysis, mechanical ventilation, continuous BiPAP, or continuous high flow oxygen by nasal cannula, or total bilirubin ≥ 3x upper limit of normal not due to GVHD. * A clinical presentation resembling de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment (except for mild oral or ocular GVHD) * Corticosteroids \>10 mg/day methylprednisolone (or other methylprednisolone equivalent, MPE) for any indication within 5 days before the onset of acute GVHD except for adrenal insufficiency or premedication for transfusions/IV meds * Participation in clinical trials using experimental agents not approved by the FDA for any indication within 14 days of enrollment or five half-lives, whichever is longer provided any prior adverse events have improved to ≤grade 1 * Patients who are pregnant or nursing * History of allergic reaction to ruxolitinib or any JAK inhibitor

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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-versus-host disease Adverse effects Allogeneic bone marrow transplantation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • City of Hope Comprehensive Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Fred Hutchinson Cancer Research Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Kansas University Medical Center

    RECRUITING

    Fairway, Kansas, 66205, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Moffitt Cancer Center

    NOT_YET_RECRUITING

    Tampa, Florida, 33612, United States

  • Ohio State University

    NOT_YET_RECRUITING

    Columbus, Ohio, 43210, United States

  • University of Pennsylvania

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Vanderbilt University

    RECRUITING

    Nashville, Tennessee, 37235, United States

  • Washington University

    NOT_YET_RECRUITING

    St Louis, Missouri, 63110, United States

  • Winship Cancer Institute, Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.