RecruitingPhase 2

Novel Therapies for Severe Acute GVHD (Graft-versus-host Disease)

China54 participantsStarted 2025-06-30

Plain-language summary

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 )

Who can participate

Age range14 Years

SexALL

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Inclusion 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.

Exclusion criteria

✕. 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.

What they're measuring

Overall response rate (ORR) at Day 28

Timeframe: Day 28 after treatment

Trial details

NCT IDNCT07509749

SponsorDaihong Liu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-30

Contact for this trial

Daihong Liu

01066937079 daihongrm@163.com

View on ClinicalTrials.gov More GVHD, Acute trials