NCT05417971Recruiting
Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation
Northside Hospital, Inc.
Start Date
8/29/2022
Completion Date
12/31/2026
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 Criteria
Age Range: 18 years to No maximum
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; active HepB or HepC
* Uncontrolled infection
* Pregnant female or not able to practice adequate contraception
* Debilitating medical or psychiatric illness which would preclude their giving informed consent
Interventions
OTHER
Fludarabine
Conditions
Hematologic Malignancy
Locations
Caitlin Guzowski
Atlanta, Georgia 30342
United States