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

Sponsor
Daihong Liu
Study ID
NCT07509749
Phase
PHASE2
Status
Recruiting
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Conditions

  • GVHD, Acute
  • Stem Cell Transplant Complications

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib and Methylprednisolone — DRUG
    Participants began oral administration of ruxolitinib at 5 mg QD; Methylprednisolone (1mg/kg)
  • Methylprednisolone — DRUG
    Methylprednisolone 2mg/kg/d , iv or iv gtt for at least 1 week, then taper according to the clinical response.

Study Details

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 )

Key Dates

Start date
Jun 30, 2025
Status verified
Mar 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib Arm
    Ruxolitinib(5mg/d) combined with Methylprednisolone(1mg/kg)
  • Active Comparator: Comparator arm
    Methylprednisolone (2mg/kg)

Primary Outcome Measure

Overall response rate (ORR) at Day 28 [ Time Frame: Day 28 after treatment ]

Central Contacts

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