Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation
Recruiting now
Conditions studied: Hematologic Malignancy
In brief
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.
Key facts
- Study ID
- NCT05417971
- Run by
- Northside Hospital, Inc.
- People needed
- 20
- Starts
- 2022-08-29
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-04-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Caitlin Guzowski — Atlanta, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
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