Ruxolitinib as add-on Therapy in Steroid-refractory Graft-vs-host Disease

Sponsor
Yi-Lun Wang
Study ID
NCT05663827
Phase
PHASE3
Status
Completed

Conditions

  • Steroid Refractory GVHD

Eligibility Criteria

Sex
ALL
Age
3 Months - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    A dosage of 5mg once daily will be applied as initiation. After one week use, dose escalation or de-escalation would depend on clinical response.

Study Details

Steroid-refractory graft-vs-host disease (SR-GVHD) is a major cause of mortality after allogeneic hematopoietic stem cell transplantation (HSCT). We sought to evaluate the effect and safety of ruxolitinib (RUX) add-on in the treatment of patients with SR-GVHD.

Key Dates

Start date
Jan 1, 2019
Status verified
Mar 2024
Primary completion
Jan 1, 2020
Completion
Nov 30, 2022

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib add-on group
    Once diagnosed with steroid-refractory GVHD, after discussion with family, as per their willing, Ruxolitinib will be administered as add-on therapy. Its dose depends on participants' age and body weight. Usually a dosage of 5mg once per day will be applied as initiation and titrated in accordance with clinical response.

Primary Outcome Measure

GI symptoms secondary to GVHD [ Time Frame: 3 years ]

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