Ruxolitinib for Steroid-refractory GVHD

Sponsor
St. Petersburg State Pavlov Medical University
Study ID
NCT02997280
Phase
PHASE2
Status
Completed

Conditions

  • Graft Vs Host Disease

Eligibility Criteria

Sex
ALL
Age
1 Year - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib Oral Tablet — DRUG
    Dose reduction criteria for acute GVHD: grade 4 neutropenia or grade 4 thrombocytopenia related to ruxolitinib administration based on the decision of attending physician. Dose reduction criteria for chronic GVHD: grade 3 neutropenia, grade 3 thrombocytopenia or anemia requiring transfusion, related to ruxolitinib administration based on the decision of attending physician. Reduced dose schedule: 5 mg bid for adults and children with body weight \> 40 kg, 0.08 mg/kg bid for children with body weight \< 40 kg. Treatment discontinuation criteria: complete response; absence of response after 28 days or progressive disease after 7 days for acute GVHD; absence of response after 84 days or progressive disease after 28 days for chronic GVHD; life-threatening complications.

Study Details

Steroid-refractory acute GVHD (srGVHD) is one of the causes of mortality after allogeneic stem cell transplantation, while steroid-refractory chronic GVHD significantly increases morbidity, aggravates quality of life and may also impact survival. Currently there is no standard treatment of srGVHD. One of the most promising agents is Janus kinase (JAK) inhibitor ruxolitinib, which in the retrospective study demonstrated excellent response rate and survival of patients with either acute or chronic srGVHD. This study prospectively evaluates the efficacy of ruxolitinib in srGVHD patients.

Key Dates

Start date
Aug 31, 2016
Status verified
Apr 2019
Primary completion
Dec 31, 2018
Completion
Apr 30, 2019

Study Design

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

Arms

  • Experimental: Ruxolitinib treatment
    Ruxolitinib 10 mg bid for adults and children with body weight \> 40 kg, 0.15 mg/kg bid for children with body weight \< 40 kg.

Primary Outcome Measure

Overall response rate [ Time Frame: 84 days ]

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