Fludarabine and Busulfan vs. Fludarabine, Busulfan and Total Body Irradiation
Key claim: A randomized single-institution trial is comparing fludarabine/busulfan versus fludarabine/busulfan plus low-dose total body irradiation as conditioning regimens for allogeneic stem cell transplantation in myeloid malignancies including MPNs, with relapse rate and transplant-related toxicity as primary endpoints.
Abstract
This is a single institution study of fludarabine and busulfan versus fludarabine, busulfan and low dose total body irradiation in patients undergoing allogeneic stem cell transplantation. A study population of 80 subjects will be enrolled from The John Theurer Cancer Center at Hackensack University Medical Center. Subjects who are eligible to receive allogeneic hematopoietic stem cell transplantation according to the eligibility criteria will be consented and enrolled. Subjects will be randomly assigned to receive one of 2 conditioning regimen: fludarabine and busulfan, or fludarabine busulfan and low dose total body irradiation (TBI). Subjects will be followed until 1 year post transplantation to assess the relapse rate in each arm and transplant-related toxicity.
The combination of fludarabine and busulfan is the current standard of care for patients with myeloid malignancies (AML, CML and other myeloproliferative disorders, or MDS) undergoing allogeneic transplantation at HUMC. In this study we will be comparing in a randomized fashion the standard regimen to a regimen of fludarabine, busulfan and TBI.
Why this matters
Conditioning regimen intensity is a core lever in MPN transplant decision-making, balancing relapse risk against transplant-related toxicity in a population that often has fibrotic marrow, splenomegaly, and prior JAK-inhibitor exposure. A randomized FluBu vs FluBu+low-dose TBI comparison directly addresses whether adding TBI meaningfully reduces relapse without unacceptable toxicity cost — a question with practical weight when matching conditioning intensity to MTSS/MIPSS70+ risk and donor type.