This phase II trial studies how well cyclophosphamide, sirolimus, and mycophenolate mofetil work in preventing graft versus host disease in patients with blood cancer undergoing donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclophosphamide, sirolimus, and mycophenolate mofetil after the transplant may stop this from happening.
Additional locations may be listed on ClinicalTrials.gov for NCT03018223.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To estimate the cumulative incidence and severity of acute graft versus host disease (GVHD) by day 100 after related haploidentical peripheral blood stem cell transplantation using the GVHD prophylaxis regimen post-transplantation cyclophosphamide (PTCy), sirolimus and mycophenolate mofetil (MMF).
SECONDARY OBJECTIVES:
I. To determine the cumulative incidence and severity of chronic GVHD by 1 year.
II. To examine additional transplantation outcomes including malignancy relapse, overall survival, progression-free survival, non-relapse mortality, and engraftment and immune reconstitution.
III. To examine peripheral blood markers of immune tolerance development.
IV. To evaluate the impact of the use of haploidentical related donors in the access of ethnic/race minority patients to allogeneic transplantation.
OUTLINE: Patients are assigned to 1 of 2 conditioning regimens determined by the treating physician.
MYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) beginning on days -6 or -5 for 4 days and busulfan IV beginning on days -6 or -5 for 4 days.
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -6 to -2 and cyclophosphamide IV on days -6 to -5. Patients also undergo total body irradiation on day -1.
TRANSPLANT: All patients undergo peripheral blood stem cell transplantation on day 0.
GVHD PROPHYLAXIS: All patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive sirolimus orally (PO) once daily (QD) or twice daily (BID) beginning on day 5 with a taper on days 90-180 and MMF IV every 8 hours on day 5 and PO daily until day 35 in the absence of acute GVHD.
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorNelli Bejanyan