A Phase II Controlled Trial of a Single ProHema-CB unit (Ex Vivo CXCR4-Upregulated CD34+ Hematopoietic Progenitor Cells, Cord Blood) As Part of a Double Umbilical Cord Blood Transplant Following Myeloablative Conditioning For Patients Age 15-55 Years With Hematologic Malignancies
ID Number 12-1687Principal Investigator(s)
Luis M. Isola
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to evaluate the safety of an investigational agent called ProHema-CB. The U.S. Food and Drug Administration (FDA) has not approved the use of ProHema-CB unit for treatment of umbilical cord blood stem cells. An investigational agent is not approved by the United States Food and Drug Administration (FDA) for use except in research studies.
The study doctors are trying to find out if ProHema-CB treatment of the donated umbilical cord stem cells you will receive may enhance the ability of these cells to start to grow and make new blood cells. The growth of stem cells after transplantation is sometimes referred to as "engraftment".
As stated above, ProHema-CB treatment is being tested to see if it can improve the ability of umbilical cord blood stem cells to grow after transplantation. One of the major problems after umbilical cord transplantation is the time required for engraftment. After transplantation with a single umbilical cord blood unit the average time to engraftment is about 3 to 4 weeks, depending on the number of stem cells in the cord blood unit. After transplantation of two umbilical cord blood units, the average time to achieve engraftment is closer to 3 weeks but this shorter time comes with a higher risk of the complication of graft versus host disease (GVHD). GVHD is a common complication of all organ and cell transplants, and your doctor will explain this problem to you in more detail. In addition, up to 10% of patients who undergo umbilical cord blood transplantation never achieve engraftment of the donated cells.
This study is a randomized study which means that you are put into a group by chance. It is like flipping a coin. You will be “randomized” into one of the two study groups described below. Neither you nor the researcher will choose what group you will be in.. You will be randomized to receive 2 umbilical cord blood units with a two to one chance of receiving one which will be a ProHema-CB treated unit.
Recruiting Patients: Yes