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Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

RECRUITINGSponsored by Northside Hospital, Inc.
Actively Recruiting
SponsorNorthside Hospital, Inc.
Started2022-08-29
Est. completion2026-07-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT05417971

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: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerHematologic Malignancy

Locations1 site

Caitlin Guzowski
Atlanta, Georgia, 30342
Caitlin Guzowski, MBA, MHA404-851-8523caitlin.guzowski@northside.com

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