RecruitingNCT05417971

Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

A Phase II Trial of Reduced Intensity Fludarabine and Total Body Irradiation-Based Conditioning Prior to Haplo-Identical Transplantation for Patients With Hematologic Malignancies

Sponsor

Northside Hospital, Inc.

Enrollment

20 participants

Start Date

Aug 29, 2022

Study Type

OBSERVATIONAL

Conditions

Hematologic Malignancy

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria8

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