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Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

Recruiting
18 years of age
Both
Phase N/A

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Overview

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

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

Study details

Hematologic Malignancy

NCT05417971

Northside Hospital, Inc.

22 April 2025

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