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Compares treatment options for GVHD, Acute
Official title Novel Therapies for Severe Acute GVHD (Graft-versus-host Disease)
ClinicalTrials.gov ID: NCT07509749
What this study is testing
What is Ruxolitinib and Methylprednisolone?
Ruxolitinib and Methylprednisolone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for gvhd, acute.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for the severe acute GVHD (graft-versus-host disease )
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join if
- diagnosed with hematological diseases.
- Have undergone first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem...
- New onset of severe acute GVHD within 100 days post-transplantation.
You likely can't join if
- Recipients of second allogeneic stem cell transplant.
- Acute GVHD induced by donor lymphocyte infusion, interferon.
- Received first line aGVHD treatment before enrollment.
- Overlap GVHD syndrome.
- Pregnant or breast-feeding women.
- Absolute neutrophil count (ANC) \<0.5×10e9/L or platelet count (PLT) \< 20×10e9/L.
See the full eligibility criteria
- diagnosed with hematological diseases.
- 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.
- New onset of severe acute GVHD within 100 days post-transplantation.
- Recipients of second allogeneic stem cell transplant.
- Acute GVHD induced by donor lymphocyte infusion, interferon.
- Received first line aGVHD treatment before enrollment.
- Overlap GVHD syndrome.
- Pregnant or breast-feeding women.
- Absolute neutrophil count (ANC) \<0.5×10e9/L or platelet count (PLT) \< 20×10e9/L.
- Serum creatinine \> 2.0 mg/dL or creatinine clearance \< 40 mL/min measured or calculated by Cockroft-Gault equation.
- Uncontrolled infection.
- Human immunodeficiency virus infection.
- Active hepatitis b virus, hepatitis C virus infection and need antivirus treatment.
- people with evidence of relapsed primary disease, or people who have been treated for relapse after the allo-HSCT was performed, or graft rejection.
- Allergic history to Janus kinase inhibitors.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.