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 hematopoietic stem cell transplant (HSCT), a Phase II study
Study Status
Open to Enrollment
Study Description
This clinical trial is for men and women with steroid-refractory acute graft versus host disease (acute GVHD) after undergoing a bone marrow transplant (BMT). Currently there is no standard treatment for steroid-refractory GVHD. This study is evaluating a drug called Tocilizumab as a first line therapy for patients with acute GVHD.
Tocilizumab is a monoclonal antibody that protects against the interleukin-6 (IL-6) receptor. IL-6 is a naturally occurring substance in the body; high levels of IL-6 have been associated with acute GVHD. Tocilizumab is FDA-approved for treating rheumatoid arthritis but not for GVHD.
The study will test the safety and efficacy of Toclizumab. There are two phases to this study, Phase IIp and and Phase II. Both phases include people with acute GVHD have not responded to steroid treatment.
- Phase IIp: The first 12 people enrolled in the study will participate in Phase IIp and will receive 8 mg/kg of Tocilizumab via infusion every two weeks for a total of 8 doses
- Phase II will be begin with the next group of people enrolled in the study
Depending on the dose they are assigned to, patients will receive Toclizumab 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, patients will be asked to follow up periodically for one year after starting Toclizumab treatment.
Disease Status and/or Stage
Steroid-Refractory Acute Graft-versus-Host Disease (GVHD)
Sponsor
Weill Cornell Medical College
Key Eligibility
- Men and women age ≥18 and ≤80 years of age
- Steroid-refractory acute GVHD stage 2 to 4. developing after bone marrow transplantation (BMT) Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- June Greenberg, RN
- (212) 746-2651
- [email protected]
- Bone Marrow Transplant Medical Practice
- (212) 746-2119
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
