Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

Northside Hospital, Inc.

Status: Enrolling

Conditions: Hematologic Malignancy

Treatments: Other: Fludarabine

Study type: Observational

Funder types: Other

Identifiers

NCT05417971

NSH 1347

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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