Status:
TERMINATED
In-vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus
Lead Sponsor:
Hackensack Meridian Health
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
In this study the investigators are proposing to treat patients with steroid-refractory Graft-versus-host Disease (GVHD) stabilization using IL-2 and azacitidine
Detailed Description
High-dose cyclophosphamide and sirolimus have been successfully used for the prevention of Graft-versus-host Disease (GVHD) and have shown to enhance the Tregs subpopulation. The addition of low dose ...
Eligibility Criteria
Inclusion
- Patients must have a documented clinical diagnosis of grade II-IV acute graft-versus- host disease defined as graft versus host disease (GVHD) occurring within the first 100 days of transplantation
- Patients must be steroid-refractory defines as progression after 3 days of corticosteroid therapy or no response after 5 days of corticosteroid therapy.
- Progression is defined as up-grading
- No response is defined as no down-grading
- Progression after 3 days requires patients to have received at least 2 mg/mg/day for a total of 6 mg/kg of methylprednisolone or its equivalent.
- No response after 5 days requires patient to have received at least 2 mg/kg/d for a total of 10 mg/kg of methylprednisolone or its equivalent.
- Patients with exacerbation of GVHD during steroid taper will require re-treatment with 2mg/kg/d of corticosteroids and will need to meet the criteria
- Age 18-70
- Patients must have received an allogeneic hematopoietic stem cell transplant within 100 days of study enrollment.
- Serum creatinine \< 2 mg/dL
Exclusion
- Patients cannot have active central nervous system (CNS) disease.
- Patients must not have received cyclophosphamide for GVHD prophylaxis
- Patients must not have pneumonia requiring oxygen supplementation
- Unable or unwilling to sign informed consent.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01453140
Start Date
August 1 2011
End Date
July 1 2012
Last Update
March 2 2022
Active Locations (1)
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1
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601