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Chronic graft versus host disease (cGVHD) is a common complication of bone marrow or hematopoietic cell transplant from another person (allogeneic transplant). This study will determine if subjects with steroid dependent/refractory cGVHD can tolerate infusion of donor regulatory T cells and whether their cGVHD responds to the infusion.
Full description
PRIMARY OBJECTIVES:
Determine the safety and tolerability of donor T regulatory (Treg) cell infusions in subjects with steroid dependent/refractory chronic graft versus host disease.
SECONDARY OBJECTIVES:
Determine the quantitative blood Treg cell changes following the cell infusions
Determine clinical efficacy of donor Treg cells as failure-free survival (FFS) defined by the absence of a new immunosuppressive therapy added, non-relapse mortality, and recurrent malignancy at Day 180 after the first Treg infusion
In addition to FFS, the study will measure the change in:
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Inclusion criteria
Steroid dependent/refractory cGVHD defined as:
Participants must be receiving systemic glucocorticoid therapy for cGVHD; all immunosuppressive therapy may include but not be limited to tacrolimus, sirolimus, CellCept, cyclosporine, and systemic corticosteroid must be at stable doses for 28 days prior to the first cell infusion
Chronic GVHD manifestations that can be followed on physical or laboratory exam; these include but are not necessarily limited to:
Karnofsky performance status >= 60
Serum creatinine =< 2 mg/dL
Absolute neutrophil count (ANC) > 1 x 10^9/L
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 20 x upper limit of normal (ULN) or
Total bilirubin =< 10 x ULN
Allogeneic hematopoietic cell transplant recipient
Transfusion independent
Oxygen saturation during exertion is maintained at >= 88% on room air
Does not have clinically significant, symptomatic uncontrolled heart disease (e.g., unstable angina, congestive heart failure, or uncontrolled hypertension)
DONOR: Age >= 18 to =< 75 years old
DONOR: Karnofsky performance status of >= 70% defined by institutional standards
DONOR: Must be the same sibling donor from whom the recipient's blood and marrow graft was collected for the original allogeneic transplant that is human leukocyte antigen (HLA) 7/8 or 8/8 matched at the HLA-A, B,C, DRB1
DONOR: Serologies for human immunodeficiency virus (HIV) antigen (Ag), HIV 1 and HIV 2 antibody (Ab), human T-lymphotropic virus type I (HTLV 1) and HTLV 2 Ab, hepatitis B surface antigen (sAg) or polymerase chain reaction positive (PCR+), or hepatitis C Ab or PCR+, Syphilis (Treponema) screen and HIV 1 and hepatitis C by nucleic acid testing (NAT) have been collected prior to apheresis
DONOR: Female donors of child-bearing potential must have a negative serum or urine beta-human chorionic gonadotropin (HCG) test within three weeks of apheresis
DONOR: Capable of undergoing leukapheresis, have adequate venous access, and be willing to undergo insertion of a central catheter should leukapheresis via peripheral vein be inadequate
DONOR: Donor selection will be in compliance with 21 Code of Federal Regulations (CFR) 1271
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14 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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