Azacitidine in Haploidentical Donor Hematopoietic Cell Transplantation
Status:
Terminated
Trial end date:
2020-10-14
Target enrollment:
Participant gender:
Summary
Allogeneic hematopoietic cell transplantation (allo-HCT) is a potentially curative therapy
for patients with hematologic malignancies including acute myeloid leukemia (AML),
myelodysplastic syndrome (MDS), and acute lymphoblastic leukemia (ALL); however, human
leukocyte antigen (HLA)-matched donor availability continues to be a major hurdle.
Historically, HLA haploidentical donor hematopoietic cell transplantation (haplo-HCT) was
associated with high incidences of graft rejection and excessive non-relapse mortality (NRM),
but recent advances utilizing post-transplant cyclophosphamide (PT-Cy) have revolutionized
haplo-HCT and the outcomes are now comparable to allo-HCT using more traditional HLA matched
related and unrelated donors. However, graft-versus-host disease (GvHD) continues to be a
problem and is associated with significant morbidity and mortality in allo-HCT patients
including those who receive haplo-HCT on PT-Cy platform. The aim of this early phase study is
to investigate the safety and overall efficacy of azacitidine in reducing the incidence and
severity of GvHD when added to PT-Cy based haplo-HCT platform for patients with AML, ALL, or
advanced MDS.