Phase II Study of Tocilizumab for Patients With Glucocorticoid-refractory Acute GVHD After Allogeneic Hematopoetic Stem Cell Transplant (HSCT)
The purpose of this study is to determine if Tocilizumab is a safe and effective treatment for steroid-refractory acute graft versus host disease.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- Response and safety of toclizumab at differing doses for treatment of subjects with glucocorticoid-refractory acute graft versus host disease [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
- Disease-free overall survival at 100 days, 6 months and one year from the time of the first tocilizumab infusion. [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
- Toclizumab response in each organ [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Effect of toclizumab on Karnofsky Performance Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: All Patients
Toclizumab will be administered on Day 0. The administration of tocilizumab will be every 2 weeks for a total of 8 doses.
8 mg/kg IV, once every 1-2 weeks. The maximum dose per infusion should not exceed 800 mg.
Other Name: ACTEMRA®
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757197
|Contact: June Greenberg, RNfirstname.lastname@example.org|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10021|
|Contact: June Greenberg, RN 212-746-2651 email@example.com|
|Principal Investigator:||Usama Gergis, MD||Weill Medical College of Cornell University|