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CD34 selected VPA expanded umbilical cord blood cells used in combination with or without unmanipulated umbilical cord blood for patients with hematological malignancies undergoing allogeneic stem cell transplantation.

VPA expanded cord blood stem cells in patients with hematological malignancies undergoing allogeneic stem cell transplantation

CD34 selected VPA expanded umbilical cord blood cells used in combination with or without unmanipulated umbilical cord blood .

Cord blood stem cells

Valproic Acid (VPA) expanded cord blood stem cells

cytoxan

Alla Keyzner, MD

In this Phase I study, the study team will evaluate the safety of Valproic Acid (VPA) expanded cord blood stem cells defined by the lack of serious infusion reactions or graft failure in patients with hematological malignancies undergoing umbilical cord blood transplantation. Moreover, the study team will also evaluate time to neutrophil and platelet engraftment as well as transplant related outcomes such as graft versus host disease (GVHD), treatment related mortality (TRM), and overall survival (OS).

This is a phase I trial for safety of VPA expanded cord blood stem cells in patients with hematological malignancies undergoing allogeneic stem cell transplantation. The primary endpoint of the study is safety as defined by the incidence of infusion reactions and graft failure, lack of neutrophil engraftment by day +42. The trial will consist of two cohorts. First cohort of 5-7 patients, will undergo double umbilical cord blood (UCB) transplantation. One UCB unit will undergo CD34 selection followed VPA based expansion. CD34 negative portion of that unit will be cryopreserved to be infused later following infusion of the expanded portion. Infusion of the second unmanipulated UCB will follow it. Preparative regimen is Fludarabine 150 mg/m2/Cytoxan 50 mg/m2/Thiotepa 10 mg/m2/TBI 400cGy.

Following successful engraftment in the first cohort, second cohort (10 patients) will only receive single manipulated unit.

Otherwise, patients will receive standard allogeneic stem cell transplantation care.

VPA Expanded UCB Transplantation for Treatment of Patients With Hematological Malignancies

Phase I Study of Valproic Acid Expanded Cord Blood Stem Cells as an Allogeneic Donor Source for Adults With Hematological Malignancies

Safety as measured by the incidence of infusion related reactions.

Safety as measured by the incidence of graft failures.

Transplant related outcomes: time to neutrophil engraftment

Transplant related outcomes: time to platelets engraftment

Transplant related outcomes: transplant-related mortality (TRM)

Transplant related outcomes: Number of disease free survivals

Transplant related outcomes: Number of overall survivals

Transplant Related Outcomes: risk of GVHD

Transplant Related Outcomes: incidence of infectious complications - which is any documented bacterial, viral, or fungal infections.

Assess the kinetics of engraftment and immune reconstitution by assessing time to myeloid engraftment

Assess the kinetics of engraftment and immune reconstitution by assessing time to lymphoid engraftment

Assess the kinetics of engraftment and immune reconstitution by assessing the T cell count at 42 days as compared to baseline

Spots Global Cancer Trial Database for cord blood stem cells