Tocilizumab for Chronic Graft-versus-Host Disease Treatment

Withdrawn before enrolling · Phase 2

Conditions studied: Graft Versus Host Disease

In brief

This phase II trial studies how well tocilizumab works in treating chronic graft-versus-host disease (GVHD) in patients that have not responded to treatment after at least two prior therapies. Tocilizumab blocks a protein that stimulates the body's immune system. By blocking this protein, the investigators may reduce the symptoms of chronic GVHD.

Key facts

Study ID

NCT02174263

Run by

Fred Hutchinson Cancer Center

People needed

0

Starts

2016-02-01

Last updated by the study team

2016-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has moderate or severe overlap chronic (c)GVHD according to National Institutes of Health (NIH) criteria
• Active cGVHD despite treatment with at least two immunosuppressive treatments (not including GVHD prophylaxis) in the past year
• Subject underwent allogeneic stem cell transplantation at least 6 months prior to enrollment
• Subject has not started any new systemic immunosuppressive therapies within 2 weeks prior to enrollment
• Female subjects of child bearing potential must have a negative pregnancy test prior to first dose of tocilizumab and must agree to practice effective contraception during the study
• Subject meets the following medication restriction requirements and agrees to follow medication restrictions during the study; the following concomitant medications are not allowed: cyclophosphamide, abatacept, etanercept, adalimumab infliximab, golimumab, tofacitinib, and alemtuzumab; these medications also cannot have been used for 5 half-lives prior to enrollment
• Subject agrees to comply with the study requirements and agrees to come to the clinic for required study visits

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.