Status:
TERMINATED
Tocilizumab for Treatment of Steroid Refractory Acute Graft-versus-Host Disease
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Acute Graft Versus Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This trial designed to evaluate the toxicity and efficacy of tocilizumab in the treatment of steroid refractory acute graft versus host disease (GVHD).
Detailed Description
Patients who underwent an allogeneic hematopoietic stem cell transplantation, with biopsy proven GVHD, active acute GVHD requiring systemic immune suppressive therapy and that failed or did not respon...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 8 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2018
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01475162
Start Date
August 8 2011
End Date
September 29 2018
Last Update
February 17 2020
Active Locations (1)
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1
Froedtert Hospital/Medical College of Wisconsin-Clinical Cancer Center
Milwaukee, Wisconsin, United States, 53226