Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Syndrome

Leukemia

Preleukemia

Myelodysplastic Syndromes

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Hematologic Neoplasms

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Bone Marrow Diseases

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

Hodgkin Lymphoma

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Anticonvulsants

Central Nervous System Depressants

Psychotropic Drugs

Antirheumatic Agents

Fludarabine

Fludarabine phosphate

Valproic Acid

Thiotepa

Cyclophosphamide

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Enzyme Inhibitors

Neurotransmitter Agents

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 expanded umbilical cord