New drug cocktail aims to tame deadly transplant complication
NCT ID NCT07509749
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether adding the drug ruxolitinib to standard steroid treatment can better control severe acute graft-versus-host disease (GVHD), a serious complication after stem cell transplants. The study will enroll 54 people who develop severe GVHD within 100 days of their transplant. The main goal is to see if more patients achieve a complete or partial response by day 28 of treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ruxolitinib and methylprednisolone
- What this could lead to
- If successful, this could offer a more effective first-line treatment for severe acute GVHD, improving response rates and survival after stem cell transplants.
- What could go wrong
- This is a small phase 2 trial with only 54 participants, so results may not apply broadly. The combination therapy also carries risks like infection and side effects from steroids.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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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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14 years and older
- 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.
Show the full entry requirements Hide 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: 1. diagnosed with hematological diseases. 2. Have undergone first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. 3. New onset of severe acute GVHD within 100 days post-transplantation. Exclusion Criteria: 1. Recipients of second allogeneic stem cell transplant. 2. Acute GVHD induced by donor lymphocyte infusion, interferon. 3. Received first line aGVHD treatment before enrollment. 4. Overlap GVHD syndrome. 5. Pregnant or breast-feeding women. 6. Absolute neutrophil count (ANC) \<0.5×10e9/L or platelet count (PLT) \< 20×10e9/L. 7. Serum creatinine \> 2.0 mg/dL or creatinine clearance \< 40 mL/min measured or calculated by Cockroft-Gault equation. 8. Uncontrolled infection. 9. Human immunodeficiency virus infection. 10. Active hepatitis b virus, hepatitis C virus infection and need antivirus treatment. 11. Subjects with evidence of relapsed primary disease, or subjects who have been treated for relapse after the allo-HSCT was performed, or graft rejection. 12. Allergic history to Janus kinase inhibitors. 13. Severe organ dysfunction unrelated to underlying GVHD, including: (1)Cholestatic disorders or unresolved veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to GVHD and ongoing organ dysfunction). (2)Clinically significant or uncontrolled cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia that requires therapy. (3)Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen. 14.Received Janus kinase inhibitor therapy after allo-HSCT for any indication. 15.Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Department of Hematology, the Fifth Center of Chinese PLA General Hospital
RECRUITINGBeijing, 100853, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Placenta cell therapy shows promise for tough transplant complication
- Blood test may spot deadly transplant complication earlier