RecruitingPhase 4

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

China36 participantsStarted 2024-07-04

Plain-language summary

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).

Who can participate

Age range12 Years – 100 Years

SexALL

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Inclusion criteria

✓. Progression based on organ assessment after at least 3 days compared to organ stage at the time of initiation of systemic corticosteroid +/- CNI for the treatment of Grade II to IV aGvHD. OR
✓. Failure to achieve at a minimum partial response based on organ assessment after 7 days compared to organ stage at the time of initiation of systemic corticosteroid +/-CNI for the treatment of Grade II to IV. OR
✓. Participants who fail corticosteroid taper defined as fulfilling either one of the following criteria:

What they're measuring

Overall Response Rate (ORR) at Day 28 per Investigators

Timeframe: Day 28

Trial details

NCT IDNCT06462469

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01-04

Contact for this trial

Novartis Pharmaceuticals

+41613241111 novartis.email@novartis.com

View on ClinicalTrials.gov More Steroid-refractory Acute Graft Versus Host Disease trials