Study of Efficacy and Safety of Ruxolitinib in Patients With Grade II to IV Steroid-refractory Acute Graft vs. Host Disease

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06462469
Phase
PHASE4
Status
Recruiting
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Conditions

  • Steroid-refractory Acute Graft Versus Host Disease

Eligibility Criteria

Sex
ALL
Age
12 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    Ruxolitinib is taken orally daily at 10 mg BID, given as two 5-mg tablets.

Study Details

The purpose of this study is to assess the efficacy and safety of ruxolitinib therapy in Chinese adults and adolescents (≥ 12 years old) with Grade II-IV steroid-refractory acute graft versus host disease (SR-aGvHD).

Key Dates

Start date
Jul 4, 2024
Status verified
Nov 2025
Primary completion
Jan 4, 2027
Completion
Feb 17, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib
    Participants will receive ruxolitinib orally of 10 mg BID daily (given as two 5-mg tablets, approximately 12 hours apart).

Primary Outcome Measure

Overall Response Rate (ORR) at Day 28 per Investigators [ Time Frame: Day 28 ]

Central Contacts