Ruxolitinib for Steroid-refractory GVHD

St. Petersburg State Pavlov Medical University

Status and phase

Completed

Phase 2

Conditions

Graft Vs Host Disease

Treatments

Drug: Ruxolitinib Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT02997280

2016-29-1

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

All

Ages

1 to 70 years old

Volunteers

No Healthy Volunteers

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