Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Donor Statin Treatment for Prevention of Severe Acute GVHD After Nonmyeloablative Hematopoietic Cell Transplantation
This phase II trial studies how well donor atorvastatin treatment works in preventing severe graft-versus-host disease (GVHD) after nonmyeloablative peripheral blood stem cell (PBSC) transplant in patients with hematological malignancies. Giving low doses of chemotherapy, such as fludarabine phosphate, before a donor PBSC transplantation slows the growth of cancer cells and may also prevent the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also cause an immune response against the body's normal cells (GVHD). Giving atorvastatin to the donor before transplant may prevent severe GVHD.
PRIMARY OBJECTIVES:
I. To assess whether 2 weeks of donor statin treatment reduces the risk of severe acute GVHD.
SECONDARY OBJECTIVES:
I. To assess whether 2 weeks of statin treatment of normal PBSC donors is feasible, tolerable
and safe.
OUTLINE:
DONOR: Donors receive atorvastatin orally (PO) once daily (QD) beginning on day -14 and
continuing until the last day of stem cell collection.
NONMYELOABLATIVE PREPARATIVE REGIMEN: If the patient is enrolled on an investigational
nonmyeloablative hematopoietic cell transplant (HCT) protocol or a treatment plan that uses a
nonmyeloablative preparative regimen with postgrafting cyclosporine (CSP) that does not use
acute GVHD as its primary endpoint, the preparative regimen and immunosuppression after
transplant will be according to respective protocol or treatment plan (Protocol 2546 serves
as adjunct protocol).
If the patient is not enrolled on an investigational nonmyeloablative HCT protocol or a
treatment plan that uses a nonmyeloablative preparative regimen, Protocol 2546 serves as an
independent primary treatment protocol. The preparative regimen and immunosuppression after
transplant is as follows:
Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 (except for
patients who had prior autologous HCT or equivalent high-dose therapy without HCT) and
undergo low-dose total body irradiation (TBI) on day 0.
TRANSPLANT: Patients undergo donor PBSC transplant on day 0.
POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56
with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every
12 hours on days 0-27.
After completion of study treatment, patients are followed up at 1 year and then annually
thereafter.
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