New combo aims to tame GVHD after stem cell transplants
NCT ID NCT07576010
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
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Jan 2025
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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Up to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
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