NCT01757197

Phase II Study of Tocilizumab for Patients With Glucocorticoid-refractory Acute GVHD After Allogeneic Hematopoetic Stem Cell Transplant (HSCT)

Tocilizumab (an Anti-human IL-6 Receptor Monoclonal Antibody) as a First Line Therapy for Patients With Glucocorticoid-refractory Acute Graft vs. Host Disease (aGVHD) After Allogeneic Hematopoetic Stem Cell Transplant (HSCT), a Phase II Study.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if Tocilizumab is a safe and effective treatment for steroid-refractory acute graft versus host disease.

Detailed description

This clinical trial is testing a drug called Tocilizumab (a monoclonal antibody) as a first line therapy for subjects with steroid-refractory acute graft versus host disease (acute GVHD) after undergoing a bone marrow transplant. The purpose of the study is to test the safety and efficacy of Tocilizumab at differing dose schedules. There are 2 phases to this study. Both phases include subjects with acute GVHD have not responded to steroid treatment. Subjects enrolled in Phase IIp will receive Tocilizumab 8 mg/kg every week or every 2 weeks. Subjects enrolled in Phase II will receive one of two dose schedules determined by the results of Phase IIp. Depending on the dose they are assigned to, subjects will receive Tocilizumab every week or every 2 weeks for a total of 8 doses. The study medication may be interrupted, withheld or stopped for different reasons. However, subjects will be asked to follow up periodically for one year after starting Tocilizumab treatment.

Conditions

• Glucocorticosteroid Refractory Acute GVHD

Interventions

Type	Name	Description
DRUG	Toclizumab	8 mg/kg IV, once every 1-2 weeks. The maximum dose per infusion should not exceed 800 mg.

Timeline

• Start date: 2013-11-07
• Primary completion: 2014-06-17
• Completion: 2014-06-17
• First posted: 2012-12-28
• Last updated: 2018-06-11
• Results posted: 2017-09-05

Locations

1 site across 1 country: United States