Status:
RECRUITING
Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation
Lead Sponsor:
Northside Hospital, Inc.
Conditions:
Hematologic Malignancy
Eligibility:
All Genders
18+ years
Brief 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
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05417971
Start Date
August 29 2022
End Date
December 31 2026
Last Update
October 30 2025
Active Locations (1)
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1
Caitlin Guzowski
Atlanta, Georgia, United States, 30342