Novel First-line Therapies for Grade II Acute GVHD(Graft-versus-host Disease )

Sponsor
Daihong Liu
Study ID
NCT07340723
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 — DRUG
    Participants began oral administration of ruxolitinib at 5 mg QD;Methylprednisolone: 0.5mg/kg/d , iv or iv gtt for at least 5 days, then taper according to the clinical response.
  • Corticosteroids — 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 grade II acute GVHD (graft-versus-host disease )

Key Dates

Start date
Jun 1, 2025
Status verified
Jun 2025
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

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

Arms

  • Experimental: Ruxolitinib Arm
    Ruxolitinib combined with Corticosteroids
  • Active Comparator: Comparator arm

Primary Outcome Measure

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

Central Contacts

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