Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-10-03; most recent amendment 2026-03-20.
Status change: Not Yet Recruiting → Recruiting 2026-01-08
Trial Details
NCT Number NCT07214688
Lead Sponsor Hackensack Meridian Health
Conditions Allogeneic Stem Cell Transplant Recipient
Enrollment 209 participants
Start Date 2026-01-06
Primary Completion 2032-01 (estimated)
Study Completion 2032-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-23