A Phase III Randomized Study of Expanded Umbilical Cord Blood Cells to Enhance Blood System Recovery in Patients with Hematologic Cancers Undergoing Stem Cell Transplantation

Protocol
13-214
Full Title
A 1-Year, Multicenter, Randomized, Open-Label Controlled Study to Evaluate the Efficacy and Safety of Umbilical Cord Blood Cells Expanded Ex Vivo with Mesenchymal Precursor Cells for Hematopoietic Recovery in Patients With Hematologic Malignancies After Myeloablative Conditioning
Phase
I
Purpose

Stem cell transplantation is often used in patients with hematologic cancers who have had chemotherapy to help rebuild their blood-forming and immune systems. But not every patient has a stem cell donor who is a close enough genetic match. In these cases, doctors may use umbilical cord blood, which is a rich source of stem cells. Cord blood collections from two newborns (a “double-unit” transplant) can be used to increase the number of cord blood cells patients receive, further enhancing their recovery. But even in this case, recovery can take a long time.

Expansion” is a method of growing cord blood cells in the laboratory to generate a larger number of blood stem cells for transplantation. In this study, researchers want to see if giving a patient with lymphoma or acute leukemia one expanded unit of cord blood plus a non-expanded unit results in faster recovery of blood counts after transplantation than giving two units of non-expanded cord blood.

Patients will be randomly assigned to receive either (a) one expanded unit of cord blood plus one non-expanded unit, or (b) two non-expanded units.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have acute myelogenous leukemia, acute lymphoblastic leukemia, non-Hodgkin lymphoma, or Hodgkin disease and require treatment with a stem cell transplant.
  • Patients may not have a matched sibling stem cell donor.
  • This study is open to patients age 65 and younger

For more information about this study and to inquire about eligibility, please contact Dr. Juliet Barker at 212-639-3468.

Disease(s)
Leukemia: Acute Lymphoblastic Leukemia
Leukemia: Acute Myelocytic Leukemia
Leukemia: Acute Myelogenous Leukemia
Lymphoma: Hodgkin's Disease
Lymphoma: Non-Hodgkin's Lymphoma
Locations