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Patients status post allogeneic hematopoietic stem cell transplantation for a neoplastic hematologic disorder with the need of a CD34 selected stem cell boost for graft failure or low graft function will receive a CD34 selected hematopoietic stem cell infusion with or without preceding conditioning.

Fludarabine 25 mg/mq day 1 - 5 + 2 Gray Total body irradiation depending on clinician's discretion (with the addition of cyclophosphamide 14.5 mg/kg for two doses for haploidentical or matched unrelated donor with at least one major HLA mismatch). Recommendation to use a conditioning regimen include complete loss of donor chimerism, trilineage cytopenias.

CD34 stem cell isolation and infusion to reduce alloreactive complication of stem cell infusion

Infusion of CD34 selected hematopoietic stem cells

Antonio Di Stasi, M.D.

Chowdury Nazma

Patients with graft failure or delayed engraftment may benefit from a hematopoietic stem cell boost or an additional hematopoietic stem cell transplantation procedure. In such settings standard immune suppression strategies are avoided due to their myelosuppressive nature. Therefore those patients are at increased risk of graft versus host disease, and the infusion of a CD34 selected graft would reduce such a risk. The infusion of CD34 selected graft using CliniMACS plus is currently FDA FDA-approved indication for acute myeloid leukemia. However, the use of the Prodigy would streamline the processing, in terms of hands-off procedure, allowing to provision of this product to the patients without strains on the cell therapy lab team. This procedure has been demonstrated safe and effective in several single-center studies and is currently in advanced phase investigation in several studies for malignant and non-malignant conditions.

Patients eligible to be treated on this status are status post allogeneic hematopoietic stem cell transplantation for a neoplastic hematologic disorder with the need of a CD34 selected stem cell boost for graft failure or low graft function (e.g. marrow cellularity reduced per age and/or dropping donor chimerism with cytopenias and/or platelets or red blood cells transfusion requirement).

Feasibility study of CD34 selection for graft versus host disease (GVHD) Prophylaxis using the automated CliniMACS Prodigy Device.

CD34 Selection Using the Automated CliniMACS Prodigy

Feasibility Study of CD34 Selection for GVHD Prophylaxis Using the Automated CliniMACS

Incidence of severe (grade III-IV) acute GVHD \<=25% at 100 days

Incidence of extensive chronic GVHD \<=10% at one year.

Clinical improvement, defined as an increase of blood counts with transfusion independence if anemia or thrombocytopenia or freedom for infections if reduced leukocytes

Rate of one-year non-relapse mortality (NRM).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CD34 Selection Using the Automated CliniMACS Prodigy	NCT06047886	AML ALL Lymphoid Malign... Myelodysplastic... CML Primary Myelofi...	Infusion of CD3...	4 Weeks - 75 Years	University of Alabama at Birmingham
CD34 Selection Using the Automated CliniMACS Prodigy	NCT06047886	AML ALL Lymphoid Malign... Myelodysplastic... CML Primary Myelofi...	Infusion of CD3...	4 Weeks - 75 Years	University of Alabama at Birmingham

Spots Global Cancer Trial Database for infusion of cd34 selected hematopoietic stem cells