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Can a Three-Drug combo shield stem cell transplant patients from a dangerous immune attack?

NCT ID NCT07796620

Disease control Sponsor: Peking University People's Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This trial tests a combination of sirolimus, ruxolitinib, and mycophenolate mofetil to prevent acute graft-versus-host disease (aGVHD) in patients receiving a half-matched stem cell transplant. The study focuses on patients with blood cancers or severe aplastic anemia who cannot tolerate standard calcineurin inhibitors due to side effects like kidney damage or high blood pressure. Researchers will measure how many patients develop moderate to severe aGVHD within 100 days after transplant, along with other outcomes like chronic GVHD and survival.

What this could mean

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

Active substance
A combination of sirolimus, ruxolitinib, mycophenolate mofetil, and anti-thymocyte globulin (ATG)
What this could lead to
If it works, this could offer a safer way to prevent graft-versus-host disease for patients who cannot tolerate standard preventive drugs, potentially improving transplant outcomes.
What could go wrong
This is an early-phase trial with only 40 participants, so the combination may not prove effective or safe. The drugs can cause side effects like infections or blood disorders.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 40 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 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

14 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: * Primary disease: hematological malignancies (including acute leukemia, myelodysplastic syndromes), nonmalignant disorders (including severe aplastic anaemia) * Renal injury or inability to tolerate the side effects of CNI: such as CNI renal toxicity (creatinine levels above the upper limit of normal), uncontrolled hypertension, and neurotoxicity rrom the time of hematopoietic stem cell infusion until +90 days after transplantation * Receiving haplo-HSCT for the first time Exclusion Criteria: * Allergy or intolerance to study drugs * Active infection * Active GVHD * Transplantation-associated thrombotic microangiopathy * Key organ dysfunction: liver injury (total bilirubin more than 2 upper limit of normal) or heart injury (symptomatic heart failure or ejection fraction\<50%) * Eastern Cooperative Oncology Group (ECOG) score \>2 * Expected survival time \<30 days * Patients could not cooperate

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Conditions

The condition(s) this trial relates to.

acquired aplastic anemia acute leukemia aplastic anemia graft versus host disease myelodysplastic syndrome Myelodysplastic Syndromes acute graft versus host disease prevention target

As listed by the trial registrant

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

Acute leukemia Myelodysplastic syndromes Severe aplastic anemia (SAA)

How to take part

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

  1. 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 ↗

  2. 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.

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