PRO#1278: A Phase III Study of Fludarabine and Busulfan Versus Fludarabine, Busulfan and Low Dose Total Body Irradiation in Patients Receiving an Allogeneic Hematopoietic Stem Cell Transplant
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 (myelogenous leukemia, chronic myelogenous leukemia, other
myeloproliferative disorder, or myelodysplastic syndrome) 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.
Primary Objective The primary objective is to compare the relapse rate at 1 year of patients
with myeloid malignancies receiving each regimen.
Secondary Objectives The secondary objective is to compare the toxicity of each regimen
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare the relapse rate at 1 year of patients with myeloid malignancies receiving each treatment
United States: Institutional Review Board
|John Theurer Cancer Center at Hackensack University Medical Center||Hackensack, New Jersey 07601|