Umbilical Cord Blood Transplant for Children With Lymphoid Hematological Malignancies
Status:
Withdrawn
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine the safety and effectiveness of UCBT to treat
patients with lymphoid hematological diseases and to see if this treatment can decrease the
incidence of leukemia relapse, GVHD and infections.
These patients have a type of blood cell disorder that is very hard to cure. This treatment
that is being used in this trial is known as a stem cell transplant. This treatment might
help the patient live longer without the disease. It uses much stronger doses of drugs and
radiation to kill the diseased cells that could be given without the transplant. We also
think that the healthy cells from the donor may help fight any diseased cells left after the
transplant.
For the transplant to take place, we will administer stem cells from a 'donor' whose cells
best 'match' the patient's. In this study umbilical cords will be the source of the stem
cells. Before the transplant, two very strong drugs plus total body irradiation will be given
to as preconditioning. This treatment will kill most of your blood-forming cells in the bone
marrow. The patient will then get then healthy stem cells.
If the patient has the disease in the central nervous system (CNS), they will receive
radiation to the head and spine before starting the conditioning. This is to try to get
disease control in the CNS. Radiation will not be given for children under 2 yrs old.
Currently, many umbilical cord blood units are available in public banks for transplantation
in patients lacking bone marrow donors. UCB transplants (UCBT) may offer several advantages
over adult bone marrow or peripheral blood stem cell transplants, including:
1. rapid availability,
2. absence of donor risk,
3. low risk of transmissible infectious diseases,
4. low risk of acute GvHD (Graft vs. Host Disease)
The three main causes of death after umbilical cord blood transplantation for these kind of
disorders are graft failure, infection and disease relapse.
In this study we are trying to address these three problems:
To help improve engraftment we will add the drug Fludarabine to Cytoxan and total body
irradiation. Fludarabine is a very strong medicine. We will try to decrease infections and
reduce leukemia relapse by using fludarabine instead of antithymocyte globulin (ATG).
Phase:
N/A
Details
Lead Sponsor:
Baylor College of Medicine
Collaborators:
Center for Cell and Gene Therapy, Baylor College of Medicine Texas Children's Hospital