Trials / Completed
CompletedNCT02997280
Ruxolitinib for Steroid-refractory GVHD
Treatment of Steroid-refractory Acute and Chronic Graft-versus-host Disease With Inhibitor of Janus Kinases
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- St. Petersburg State Pavlov Medical University · Academic / Other
- Sex
- All
- Age
- 1 Year – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ruxolitinib Oral Tablet | 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. |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2018-12-01
- Completion
- 2019-04-01
- First posted
- 2016-12-20
- Last updated
- 2019-04-05
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT02997280. Inclusion in this directory is not an endorsement.