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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

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Conditions

Hematologic Malignancy

Locations

Caitlin Guzowski

Atlanta, Georgia 30342

United States