Phase II Study of Tocilizumab for Patients With Glucocorticoid-refractory Acute GVHD After Allogeneic Hematopoetic Stem Cell Transplant (HSCT)
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|ClinicalTrials.gov Identifier: NCT01757197|
Recruitment Status : Terminated (Slow accrual)
First Posted : December 28, 2012
Results First Posted : September 5, 2017
Last Update Posted : June 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glucocorticosteroid Refractory Acute GVHD||Drug: Toclizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||November 7, 2013|
|Actual Primary Completion Date :||June 17, 2014|
|Actual Study Completion Date :||June 17, 2014|
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®
- Number of Subjects With GVHD Who Are Tolerable to Tocilizumab After Having Failed Response to Glucocorticosteroid Treatment [ Time Frame: Day 28 ]Both subjects enrolled on this study experienced failed response to glucocorticosteroid treatment but were able to tolerate tocilizumab. We were unable to collect extensive data on these 2 subjects because they both died early on in the study due to disease complications.
- 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 ]We were unable to evaluate disease-free survival at 100 days, 6 months and one year from the time of the first tocilizumab infusion. All subjects enrolled on this study died before this time point and the study closed to enrollment due to slow accrual.
- Toclizumab Response in Each Organ [ Time Frame: 1 year ]We were unable to assess the Tocilizumab response in each organ at 1 year. All subjects enrolled on this study died before this time point and the study closed to enrollment due to slow accrual.
- Effect of Toclizumab on Karnofsky Performance Status [ Time Frame: 1 year ]We were unable to evaluate the effect of tocilizumab on Karnofsky Performance Status at 1 year. All subjects enrolled on this study died before this time point and the study closed to enrollment due to slow accrual.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757197
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10021|
|Principal Investigator:||Usama Gergis, MD||Weill Medical College of Cornell University|