Leukemia Clinical Trial
Official title:
A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients With Severe Aplastic Anemia, Inborn Errors in Metabolism, or Inherited Hematologic Stem Cell Disorders
RATIONALE: Umbilical cord blood transplantation may allow doctors to give higher doses of
chemotherapy or radiation therapy and kill more cancer cells.
PURPOSE: This phase II trial is studying how well umbilical cord blood transplantation works
in treating patients with severe aplastic anemia, malignant thymoma, or myelodysplasia.
OBJECTIVES:
- Determine the rates of durable engraftment in patients with severe aplastic anemia,
myelodysplastic syndrome, inborn errors of metabolism, or inherited hematopoietic
disorders, refractory to medical management, who are undergoing high-dose
chemoradiotherapy followed by unrelated cord blood (UCB) transplantation.
- Evaluate the rate and quality of immunologic reconstitution in this patient population.
OUTLINE: Patients are stratified according to weight (under 45 kg vs over 45 kg).
Patients receive high-dose chemotherapy and/or radiotherapy as a conditioning regimen
beginning 6-9 days before the umbilical cord blood transplant (UCBT). The regimen varies
according to the underlying cause of the anemia, but could include busulfan,
cyclophosphamide or melphalan, anti-thymocyte globulin or methylprednisolone, and/or
radiation therapy. One day after the conditioning regimen is completed, patients receive the
UCBT.
Patients are followed weekly for 3 months, at 6 months, then every 6 months for 2.5 years,
then annually thereafter.
PROJECTED ACCRUAL: A total of 4-90 patients will be accrued for this study within 5 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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