PRO#1278: Fludarabine and Busulfan vs. Fludarabine, Busulfan and Total Body Irradiation
Status:
Active, not recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Hackensack Meridian Health Hackensack University Medical Center