A Phase II Trial of Reduced Intensity Fludarabine and Total Body Irradiation-Based Conditioning Prior to Haplo-Identical Transplantation for Patients With Hematologic Malignancies
Northside Hospital, Inc.
Summary
This trial will evaluate the safety and efficacy of RIC HIDT transplant protocol following fludarabine and intermediate-dose TBI 800 cGy utilizing PBSC as the stem cell source.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Availability of 3/6 - 5/6 matched related donor with a negative HLA-cross match in the host vs. graft direction willing to donate peripheral blood stem cells * KPS \>/= 70% * Hematologic malignancy requiring allogeneic transplantation, with a predicted high risk of relapse following non-myeloablative, low intensity conditioning. Exclusion Criteria: * Poor cardiac function (LVEF \<45%) * Poor pulmonary function (FEV, FVC, DLCO \<60%) * Poor liver function (bilirubin \>/= 2.5mg/dL; AST or ALT \>3xULN) * Poor renal function (creatinine clearance \<40mL/min) * HIV-positive…
Interventions
- OtherFludarabine
Reduced-intensity fludarabine with intermediate-dose TBI
Location
- Caitlin GuzowskiAtlanta, Georgia