Fludarabine and Intermediate-dose TBI Followed by PTCy in Patients Undergoing Allo Transplant for Heme Malignancies
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHackensack Meridian Health
About this trial
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.
Eligibility criteria
Qualifiers
Patients ages 18-65 years.
Acute myeloid leukemia or chronic myeloid leukemia with no circulating blasts and less than 5% blasts in the bone marrow;
Myelodysplastic syndrome with less than 5% blasts in the bone marrow by IHC or flow cytometry whichever is highest;
Myeloproliferative neoplasms with less than 5% blast in the marrow and peripheral blood;
Disqualifiers
Hematopoietic cell transplantation comorbidity index above 3.
Patients with a Karnofsky performance status (KPS) of <60%.
Patients with active infections or other contraindications for allogeneic stem cell transplant.
Patients who are unable or unwilling to give informed consent.
Trial design
Treatments tested in this trial
- Fludarabine
- Intermediate-dose Total Body Irradiation (TBI)
- Post-transplant Cyclophosphamide (PTCy)
- Tacrolimus
- Mycophenolate mofetil (MMF)
Treatment groups
209 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov