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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

209

Participants

Timeline

Start Date

October 15, 2025

Primary Completion Date

October 15, 2031

Study Completion Date

October 15, 2031

Conditions
Allogeneic Stem Cell Transplant Recipient
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.

Trial Locations (3)

20007

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington D.C.

07601

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

07753

John Theurer Cancer Center at Jersey Shore University Medical Center, Neptune City

All Listed Sponsors
lead

Hackensack Meridian Health

OTHER