Tocilizumab for Chronic Graft-versus-Host Disease Treatment

Exclusion Criteria

• •Donor lymphocyte infusion in the preceding 100 days
• •Subject has bronchiolitis obliterans, bronchiolitis obliterans with organizing pneumonia or cryptogenic organizing pneumonia as the sole manifestation of cGVHD
• •Uncontrolled bacterial, viral infection or invasive fungal infection
• •Evidence of malignancy within 6 months of study enrollment; this is defined as clear morphologic, radiologic or molecular evidence of disease; mixed chimerism is allowed at the discretion of the clinician
• •Treatment with any non-Food and Drug Administration (FDA) approved agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of study enrollment
• •Immunization with a live, attenuated vaccine within 4 weeks prior to study enrollment
• •History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
• •Tuberculosis requiring treatment within the past 3 years; all patients must have a negative quantiferon test within 4 weeks prior to starting study drug
• •Pregnant or breast-feeding women
• •Patients (both men and women) with reproductive potential not willing to use an effective method of contraception
• •Serum creatinine \> 1.6 mg/dL (141 umol/L) in females and \> 1.9 mg/dL (168 umol/L) in males; patients with serum creatinine values exceeding these limits are eligible for the study if their estimated glomerular filtration rates (GFR) are \> 30 ml/min/1.73 m\^2
• •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 times upper limit of normal (ULN)
• •Total bilirubin \> upper limit of normal (ULN)
• •Absolute neutrophil count \< 1.5 x 10\^9/L (1500/mm\^3)
• •Known active hepatitis B or C; patients must have a negative test for hepatitis B surface antigen, hepatitis B core antibody and hepatitis C antibody within 4 weeks prior to starting study drug
• •Known uncontrolled cytomegalovirus (CMV) polymerase chain reaction (PCR) reactivation per institutional standards; once CMV has been treated and stable per institutional standards, patient may be enrolled; CMV PCR will be tested within two weeks prior to starting study drug
• •History of diverticulitis, Crohn's disease or ulcerative colitis
• •History of demyelinating disorder