Tocilizumab for Treatment of Steroid Refractory Acute Graft-versus-Host Disease
Stopped early · Phase 1/Phase 2
Conditions studied: Acute Graft Versus Host Disease
In brief
This trial designed to evaluate the toxicity and efficacy of tocilizumab in the treatment of steroid refractory acute graft versus host disease (GVHD).
Key facts
- Study ID
- NCT01475162
- Run by
- Medical College of Wisconsin
- People needed
- 14
- Starts
- 2011-08-08
- Expected to finish
- 2018-09-29
- Last updated by the study team
- 2020-02-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Froedtert Hospital/Medical College of Wisconsin-Clinical Cancer Center — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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