Michael Pulsipher
This is a phase II, open-label, non-randomized, prospective study of haploidentical transplantation using KIR-favorable donors for children with acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT). The relationship of KIR2DL1 polymorphisms to survival in children with these diseases undergoing any approach to allogeneic HCT during the study time frame will also be determined.
Allogeneic hematopoietic stem cell transplantation (HCT) using matched related and unrelated donors is well-accepted therapy for children with subtypes of high-risk acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML). For the 40-50% of children who do not have matched donors available, HCT approaches have varied by center and regional preferences. HCT physicians in France and North America tend to use human leukocyte antigen (HLA)-mismatched umbilical cord blood (UCB), while those in many large centers in Germany, parts of Asia, and selected US centers favor HLA-haploidentical…
Inclusion Criteria: 2.3.1 Inclusion Criteria for the Biology (KIR2DL1 Polymorphisms/ALL MRD), Comparative Outcomes, and Cost Effectiveness Trial 1. Any patient with ALL, AML, or MDS who is deemed eligible for and undergoes HCT at participating centers who provides consent for the KIR2DL1 polymorphisms, comparative outcomes and cost-effectiveness portion of the trial. 2. Any ALL patient undergoing allogeneic HCT at participating centers is eligible for the ALL deep sequence MRD portion of the trial. 3. Patients ineligible for the KIR-favorable haploidentical phase II trial who require T-cell…
Graft ex vivo depleted of T cell receptor (TCR) αβ+CD3+/CD19+ cells