Umbilical Cord Blood Transplant for Children With Lymphoid Hematological Malignancies (UCALL)
After the eligible criterion for treatment has been met and a suitable UCB stem donor has
been found, the patient will have a central line placed.
After placement of the central line, the following chemotherapy will be given to after
admission to the hospital and before the infusion of the umbilical cord blood stem cells:
- 9 - 6 days before the infusion: Total Body Irradiation (TBI) in two fractions ("doses")
- 5 - 2 days before the infusion: Cytoxan given daily for 4 days, over 1 hour as an
intravenous infusion. Mesna will be given per standards. Mesna is a drug given to
decrease the side effects of Cytoxan. It will be given daily as an intravenous infusion
while the patient receives the Cytoxan.
- 4 - 2 days before the infusion: Fludarabine given daily for 3 days over 1 hour as an
Stem cell transplant (intravenous infusion of the UCB stem cells) - defined as day 0 of the
treatment. All other "numbered" days relate to this infusion date. For example, Day 1 is the
first day after the stem cell transplant.
The following medications will be given to help decrease side effects from the chemotherapy
and UCB infusion: Cyclosporine A (CSA) will be given starting 3 days prior to the stem cell
infusion. It will be given daily over 2 hours every 12 hours, after the infusion and then
tapered if no GVHD is present.
Administration of Mycophenolate mofetil (MMF) will start on the day the stem cell infusion
is completed and will continue daily for 45 days, unless the patient develops GvHD.
Intravenous immunoglobulin's (IVIG) will be given monthly until GVHD therapy is stopped and
there is evidence that the patient's body is producing antibodies.
Study Evaluations: Various study evaluations will be performed before and during the trial.
Follow Up: After year 1, the patient will be asked to return to the clinic once a year for
consultations and bone marrow tests. A follow up bone marrow biopsy and aspirate will be
done 1 and 2 years after transplant. Consultations with specialists will be similar to the
ones the patient had before the transplant.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival at 1 year after UCB transplant in pediatric patients
To determine the survival rate at 1 year after umbilical cord blood transplant in pediatric patients with lymphoid hematological malignancies
Caridad A Martinez, MD
Baylor College of Medicine
United States: Institutional Review Board
|Texas Children's Hospital||Houston, Texas|