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

Conditions

• Allogeneic Stem Cell Transplant Recipient

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Fludarabine — DRUG
  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) — RADIATION
  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) — DRUG
  Patients will receive post-transplant cyclophosphamide (PTCy) administered at the dose of 40 mg/kg intravenously on Days +3 to +4.
• Tacrolimus — DRUG
  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) — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jan 6, 2026

Status verified

Mar 2026

Primary completion

Jan 31, 2032

Completion

Jan 31, 2032

Study Design

Enrollment

209 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Experimental
  Fludarabine and Intermediate-dose Total Body Irradiation (800 cGy) Followed by Post-transplant Cyclophosphamide

Primary Outcome Measure

Overall survival (OS) at 1-year following treatment with fludarabine plus intermediate-dose total body irradiation (TBI 800 cGy) with post-transplant cyclophosphamide (PTCy) [ Time Frame: Patient status (dead or alive) will be reviewed (e.g., through patient chart review,patient phone call, etc.) up through a period of 1 year ]

Central Contacts

• Oncology Clinical Research Referral Office
  551-996-1777
  [email protected]

Locations (3)

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