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New combo aims to tame GVHD after stem cell transplants

NCT ID NCT07576010

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tests whether combining a low-dose steroid with the drug ruxolitinib can better control grade II acute graft-versus-host disease (GVHD) after a stem cell transplant. GVHD occurs when donor immune cells attack the recipient's body. The trial includes 30 people with certain blood cancers who have received a transplant. Researchers will track how long patients stay free of severe GVHD, relapse, or death.

What this could mean

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

Active substance
low-dose methylprednisolone (steroid) plus ruxolitinib
What this could lead to
If successful, this could offer a more effective first-line treatment for grade II acute GVHD, reducing the need for stronger immunosuppression and improving outcomes after stem cell transplant.
What could go wrong
This is a very early Phase 1 study with only 30 participants, so results may not apply broadly. The combination may cause side effects or fail to improve survival compared to standard therapy.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

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

Started

Jan 2025

Expected to finish

Dec 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

Up to 75 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: * Patients with malignant hematologic diseases eligible for allogeneic hematopoietic stem cell transplantation, including MDS-RAEB, acute leukemia, and chronic phase of CML. * Availability of an HLA-matched sibling donor, unrelated donor, or haploidentical donor. * Age ≥ 14 years. * Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN), total bilirubin ≤ 2 × ULN. * Renal function: serum creatinine ≤ ULN. * Absence of uncontrolled infection or severe psychiatric/psychological disorders. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. * Signed informed consent. * Diagnosis of grade II acute GVHD as assessed by the modified Glucksberg grading criteria for acute GVHD. Exclusion Criteria: * Absence of an allogeneic donor. * Pregnancy of either the donor or the recipient. * Presence of psychiatric disorders or other conditions that preclude compliance with the study protocol.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853, China

More trials for these conditions

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