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RECRUITING
NCT07214688
PHASE2

Fludarabine and Intermediate-dose TBI Followed by PTCy in Patients Undergoing Allo Transplant for Heme Malignancies

Sponsor: Hackensack Meridian Health

View on ClinicalTrials.gov

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

DRUG

Fludarabine

Patients will receive fludarabine administered at the dose of 30 mg/m2 intravenously daily on Days -6 to -2

RADIATION

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

DRUG

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.

DRUG

Tacrolimus

Patients will receive tacrolimus administered at a dose adjusted to maintain trough levels between 5-15 ng/mL orally starting on Days +5.

DRUG

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