Tocilizumab for Treatment of Steroid Refractory Acute Graft-versus-Host Disease

• Status: Terminated
• Trial end date: 2018-09-29
• Target enrollment: 0
• Participant gender: All

Summary

This trial designed to evaluate the toxicity and efficacy of tocilizumab in the treatment of steroid refractory acute graft versus host disease (GVHD).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College of Wisconsin

Criteria

Inclusion Criteria:

• Patients age 18 and older who underwent an allogeneic hematopoietic stem cell transplantation.

• Patients are required to have biopsy proven GVHD.

• Patients must have active acute GVHD requiring systemic immune suppressive therapy and that failed or did not respond to first line of therapy.

• First line therapy needs to be a minimum of corticosteroids, methylprednisolone of 1.6mg/kg/day or prednisone of 2mg/kg/day, alone or combined to other agent.

• Failure of GVHD therapy is defined as flare of signs and symptoms of acute GVHD or progression of GVHD grade after at least 72 hours from starting therapy.

• No response to GVHD treatment (corticosteroids ± other agent) after a minimum of 7 days of treatment.

• Patient must be able to give informed consent.

Exclusion Criteria:

• Intolerance or allergy to Tocilizumab

• Active uncontrolled infection requiring ongoing treatment with antifungals, antibiotics or anti-viral drugs.

• Relapsed/persistent malignancy requiring rapid immune suppression withdrawal.

• Liver enzymes: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 3x upper limit of normal.

• Patients with severe sinusoidal obstruction syndrome who in the judgment of the treating physician are not expected to have normalized bilirubin by day 56 after enrollment.

• Serum bilirubin > 2x upper limit of normal.