Protocol
UCBT01: Umbilical Cord Blood Transplantation In Patients With Hematologic Malignancies Using A Myeloablative Preparative Regimen
Diseases
Stem Cell / Bone Marrow Transplant : High risk hematologic malignancies
Description
This study offers treatment for high risk cancers, or cancer that has either 1) relapsed (come back) or, 2) cannot be found in the patient’s body (remission), but is at high risk for relapsing. This means this type of cancer may be difficult to treat or cure. A type of treatment for this type of cancer is called an allogeneic stem cell transplant. An allogeneic transplant means that the transplanted stem cells will come from someone other than the patient. This study investigates the outcomes of participants who have specific high-risk cancers and have been treated with a stem cell transplant using stem cells obtained from the umbilical cord of an unrelated donor.
Standard stem cell transplantation starts with giving chemotherapy drugs to kill the patient’s bone marrow to make space for the new stem cells. Stem cells are young blood cells that can grow to make new blood cells such as white blood cells (part of the immune system and the body’s defense system) to help fight infection, platelets to help the blood clot, and red blood cells that help to carry oxygen to the body’s vital organs. Donor stem cells are needed in order to “rebuild” the patient’s marrow that has been killed from the chemotherapy, and replace the diseased marrow with healthy donor cells. Giving (infusing) the stem cell graft to the patient is called “a stem cell transplant.”
Unfortunately, many patients do not have a matched sibling or a volunteer unrelated donor. Many patients who do not have a “match” may have a cord blood “match”. Thus, they may still undergo a stem cell transplant using stem cells are cells that have been collected from the umbilical cord of an unrelated donor at the time of birth. A matched unrelated volunteer cord blood donor will be used to provide the stem cells for this transplant through an available donor registry.
Stem cells from an unrelated cord blood donor will not be as closely matched as those from a brother or sister. As a result, there is a higher chance of problems related to the stem cell transplant. Such problems include failure of the donor cells to grow (graft failure), and a condition called graft-versus-host disease (GVHD). GVHD occurs when the donor cells (the graft) recognize that the body tissues of the patient (the host) are different. Both of these conditions can be life threatening, or even fatal (cause death).
Objectives
The purpose of this study is to learn more about the effects (good and bad) of infusing stem cells obtained from umbilical cord blood.
- The overall survival rate of participants who receive this study procedure.
- The number of participants who experience relapse of their disease.
- How often participants experience GVHD.
- How the donor cells grow and work in the recipient’s body after infusion.
- How the body absorbs, uses, eliminates, and “handles” a medication called mycophenylate mofetil (MMF).
Eligibility
- Age less than or equal to 21 years old
- All patients with evidence of CNS leukemia must be treated and be in CNS CR to be eligible for study.
- Patient with down syndrome, who is lactation or pregnant will not be eligible for the study
For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).
Contact
Mari Hashitate Dallas, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-595-5068
Referring or consulting physicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org
The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.