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Can a psoriasis drug stop transplant rejection?

NCT ID NCT04572815

Disease control Sponsor: Fred Hutchinson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase II trial tests whether the drug ustekinumab (Stelara) can prevent acute graft-versus-host disease (GVHD) in 116 adults receiving stem cell transplants for blood cancers. GVHD occurs when donor immune cells attack the patient's body. Ustekinumab aims to calm this immune response. Participants receive either the drug or a placebo, and researchers track how many develop GVHD over time.

What this could mean

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

Active substance
ustekinumab (Stelara)
What this could lead to
If it works, this could offer a new way to prevent graft-versus-host disease, a serious complication after stem cell transplants.
What could go wrong
This is an early phase II trial with only 116 participants, so results may not apply to everyone. The drug may not reduce GVHD risk and could have side effects like infection.

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

116 people

The number who actually took part.

Started

May 2021

Expected to finish

Jun 2027

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 to 70 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: * Age 18 - 70 * Signed informed consent. * Hematologic malignancy or disorder requiring allogeneic hematopoietic cell transplantation * Adequate vital organ function: 1. Left ventricular ejection fraction (LVEF) ≥ 50% 2. Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and diffusion capacity of the lung for carbon monoxide (DLCO) ≥ 50% of predicted values on pulmonary function tests 3. Transaminases (aspartate aminotransferase \[AST\], aspartate aminotransferase \[ALT\]) \< 3 times upper limit of normal values 4. Creatinine clearance ≥ 50 cc/min. * Performance status: Karnofsky Performance Status Score ≥ 70%. * HCT donor is at least 8/8 (matched at HLA-A, -B, -C, -DRB1) matched with the recipient * PBSC (peripheral blood mobilized stem cells) as graft source * Fully myeloablative, reduced-toxicity ablative, or reduced-intensity conditioning regimens. If melphalan is part of the conditioning regimen, dose must be at least 75mg/m\^2 Exclusion Criteria: * Active infection not controlled with appropriate antimicrobial therapy * Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection * Anti-thymocyte globulin (ATG) as part of the conditioning regimen or GVHD prophylaxis * Pregnant or nursing women * Subjects of childbearing age unwilling to use an effective birth control method or refrain from sexual intercourse until 15 weeks after last dose of study drug * Non-myeloablative conditioning regimens or conditioning regimens that use less than 75mg/m\^2 of melphalan * Prior allogeneic transplant * Non-malignant blood disorders (e.g. sickle cell disease, aplastic anemia) * Positive screening test for tuberculosis

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Conditions

The condition(s) this trial relates to.

graft versus host disease hematologic disorder hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm acute graft versus host disease prevention target

As listed by the trial registrant

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

Hematologic and lymphocytic disorder Hematopoietic and lymphoid system neoplasm

Contacts and locations

Locations

  • City of Hope Comprehensive Cancer Center,

    Duarte, California, 91010, United States

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109, United States

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

More trials for these conditions

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