A Phase II Study of Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Related Donor Hematopoietic Cell Transplantation
I. To determine the incidence and severity of acute GVHD (aGVHD) following human leukocyte
antigen (HLA) matched related donor hematopoietic peripheral blood transplant in patients
with hematologic malignancies that receive the immunosuppressive combination of Tacrolimus
and Thymoglobulin (anti-thymocyte globulin) as GVHD prophylaxis.
II. To determine the safety of this combination in the first six months post transplant.
I. To determine engraftment time of neutrophils (absolute neutrophil count > 0.5 x 10^9/L
for 3 consecutive days), and platelets (platelet count > 20 X 10^9/L for 3 consecutive
II. To determine incidence of opportunistic infections, defined as infection that occurs in
people with weakened immune systems and caused by an organism that does not normally cause
disease. These include: fungal infections, pneumocytics carinii pneumonia (PCP), and viral
infections (cytomegalovirus [CMV], varicella zoster virus [VZV], herpes simplex virus [HSV],
BK virus [BK], Epstein-Barr virus [EBV], including post-transplant lymphoproliferative
III. To estimate incidence of chronic GVHD (cGVHD) at two years. IV. To determine overall
and disease free survival at two years. V. To assess immune response with immunocorrelative
studies both pre and at various points post transplant.
GVHD PROPHYLAXIS: Patients receive tacrolimus intravenously (IV) continuously or orally (PO)
on days -3 to 60 with taper to day 100 (high-risk disease) or on days -3 to 100 with taper
to day 180 (low-risk disease). Patients also receive anti-thymocyte globulin IV over 4-6
hours on days -3 to -1.
PREPARATIVE REGIMEN: Patients receive standard of care (at the Karmanos Cancer Institute)
preparative regimens chosen by the treating physician, based on diagnosis.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
After completion of study treatment, patients are followed up for 2 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Proportion of aGVHD graded according to the Glucksberg criteria
aGVHD is defined as any GVHD occurring within the first 100 days after transplant
During the first 6 months post-transplant
Barbara Ann Karmanos Cancer Institute
United States: Institutional Review Board
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|