Azacitidine in Haploidentical Donor Hematopoietic Cell Transplantation | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02750254

Azacitidine in Haploidentical Donor Hematopoietic Cell Transplantation
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

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.

Status: 
Not yet recruiting
Study Date: 
Fri, 07/01/2016 to Thu, 11/01/2018
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: Fludarabine Other Names: Fludara 2-Fluoro-ara-A Monophosphate 2-Fluoro-ara AMP FAMP Radiation: Fractionated total body irradiation Drug: Busulfan Other Names: Myerlan Busulphan Drug: Cyclophosphamide Other Names: Cytoxan CPM CTX CYT Radiation: Single dose total body irradiation Drug: Melphalan Other Names: Alkeran Phenylalanine mustard Drug: Granulocyte-colony stimulating factor Other Names: G-CSF Plerixafor Mozobil Neupogen Filgrastim Procedure: Stem cell transplant Drug: Azacitidine Other Names: Vidaza Ladakamycin