Ruxolitinib for Steroid-refractory GVHD

• Status: Completed
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Petersburg State Pavlov Medical University
• Collaborator: Ministry of Health, Russian Federation

Criteria

Inclusion Criteria:

• Diagnosis of graft-versus-host disease established based on tissue biopsy

• Steroid-refractory acute or chronic graft-versus-host disease according to EBMT/ELN criteria (T. Ruutu et al, 2014)

• Age 1 to 70 years

• Karnofsky index >30%.

• Ability for oral drug intake

• Life expectancy > 1 month

• Signed informed consent

Exclusion Criteria:

• Severe organ dysfunction: AST or ALT >5 upper normal limits (excluding cases related to liver GVHD), creatinine >2 upper normal limits

• Requirement for vasopressor support at the time of enrollment

• Uncontrolled bacterial or fungal infection at the time of enrollment

• Pregnancy

• Somatic or psychiatric disorder making the patient (or legal guardian) unable to sign informed consent