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Fludarabine and Intermediate-dose TBI Followed by PTCy in Patients Undergoing Allo Transplant for Heme Malignancies
Sponsor: Hackensack Meridian Health
Summary
The Flu-TBI 800 trial is a prospective, single-arm, multicenter, interventional phase 2 study to evaluate whether fludarabine plus intermediate-dose total body irradiation (TBI 800 cGy) with post-transplant cyclophosphamide (PTCy) (experimental regimen) improves the 1-year survival of allogeneic stem cell transplant recipients.
Official title: A Phase 2 Study of Fludarabine and Intermediate-dose Total Body Irradiation (800 cGy) Followed by Post-transplant Cyclophosphamide in Patients Aged 18-65 Undergoing Allogeneic Stem Cell Transplant for Hematologic Malignancies
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
209
Start Date
2026-01-06
Completion Date
2032-01
Last Updated
2026-03-23
Healthy Volunteers
No
Interventions
Fludarabine
Patients will receive fludarabine administered at the dose of 30 mg/m2 intravenously daily on Days -6 to -2
Intermediate-dose Total Body Irradiation (TBI)
Patients will receive intermediate-dose total body irradiation (TBI) administered at the dose of 800 cGy in 4 total fractions, 2 fractions per day on Days -2 to -1
Post-transplant Cyclophosphamide (PTCy)
Patients will receive post-transplant cyclophosphamide (PTCy) administered at the dose of 40 mg/kg intravenously on Days +3 to +4.
Tacrolimus
Patients will receive tacrolimus administered at a dose adjusted to maintain trough levels between 5-15 ng/mL orally starting on Days +5.
Mycophenolate mofetil (MMF)
Patients will receive mycophenolate mofetil (MMF) administered at the standard dose of 15 mg/kg orally three times daily starting on Day +5 to Day +35 or per institutional guidelines.
Locations (3)
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
John Theurer Cancer Center at Jersey Shore University Medical Center
Neptune City, New Jersey, United States