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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. 2 versions Re-verified since Feb 17, 2026, no change to tracked fieldsv4-v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Nov 15, 2031 to Jan 2032
    • Start date changed from estimate of Nov 15, 2025 to Jan 6, 2026
    • Site details revised at 3 of 3 sites
    v3
  3. Start date: Oct 15, 2025 to Nov 15, 2025
    • Primary and study completion dates: Oct 15, 2031 to Nov 15, 2031
    • Secondary endpoints revised (7)
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07214688
Lead Sponsor Hackensack Meridian Health
Conditions
(from sponsor)		 Allogeneic Stem Cell Transplant Recipient
Enrollment 209 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov