Children, adolescents, and young adults with malignant and non-malignant conditionsundergoing an allogeneic stem cell transplantation (AlloSCT) will have the stem cells selected utilizing α/β CD3+/CD19+ cell depletion. All other treatment is standard of care.
ALL:ALL high risk including one or more of the following: (t(9;22) or 11q23 chromosomal abnormality, primary induction failure (<15% blasts at time of registration), mixed phenotype acute leukemia (MPAL), persistent MRD (<0.01% by flow or persistent abnormal karyotype detected by cytogenetics) or hypodiploidy (44 chromosomes)) in first remission ' ALL in second remission and beyond;
AML: History of AML induction/reinduction Failure (<15% blasts at time of registration); AML in CR1 with poor cytogenetics (i.e. 12p, 5a, -7, FLT3 mutation/duplication, t(9;11) and others); AML with persistent minimal residual disease (MRD) in CR1(<0.01% on flow or persistent abnormal karyotype detected by cytogenetics); AML CR2 or beyond; AML in refractory relapse but ≤15% bone marrow leukemia blasts; Therapy-related AML
High Risk Myelodysplastic syndrome (MDS) 4 Lymphoma: Hodgkin (HL) or Non-Hodgkin (NHL): HL or NHL in induction failure; HL or NHL in PR1 or PR2 ; HL or NHL in CR2 or subsequent remission
Females who are pregnant or breast-feeding are not eligible.
Patients with documented uncontrolled infection at the time of study entry are not eligible.
Karnofsky/Lansky (age appropriate) Performance Score <60
Demonstrated lack of compliance with medical care
Single group
alpha beta depletion
Drugdonor cells will be collected and subsequently undergo α/β CD3+/CD19+ cell depletion.
incidence of adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells
patients will be monitored for any adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells
incidence of hematpoitic engraftment following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion
patients will have routine chimerism performed to monitoring engraftment of donor cells
incidence of GVHD following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion
patients will be monitored post transplant for signs of acute and chronic GVHD
Click on the lead sponsor to view all of their trials.
Mitchell Cairo
Lead sponsor
New York Medical College
Sponsor institution
