Lymphoma Clinical Trial
Official title:
The Use Of Umbilical Cord Blood As A Source Of Hematopoietic Stem Cells
RATIONALE: Umbilical cord blood transplantation may be able to replace immune cells that
were destroyed by chemotherapy or radiation therapy.
PURPOSE: This phase II trial is studying how well umbilical cord blood works as a source of
stem cells in treating patients with types of cancer as well as other diseases.
OBJECTIVES:
Primary
- Determine the impact of the use of umbilical cord blood as a source of hematopoietic
stem cells for children with life-threatening oncologic, hematologic, or
genetic/metabolic disorders in need of a stem cell transplant.
- Compare the incidence of graft-versus-host disease in patients receiving cord blood
transplants in this study with historical data for unrelated donor stem cell
transplants.
- Compare the incidence of engraftment in patients receiving cord blood transplants in
this study with historical data for unrelated donor stem cell transplants.
OUTLINE:
- Preparative therapy: Patients are treated on 1 of 4 preparative therapy regimens.
- Regimen A: Patients undergo total body irradiation (TBI) two times daily on days
-7 to -4. Patients receive cyclophosphamide IV over 30-60 minutes on days -3 and
-2 and anti-thymocyte globulin (ATG) IV over at least 6 hours on days -3 to -1.
- Regimen B (patients who do not receive TBI): Patients receive oral busulfan 4
times daily on days -8 to -5, and ATG IV over at least 6 hours and melphalan IV
over 15-20 minutes on days -4 to -2.
- Regimen C (patients with Fanconi's anemia and related disorders): Patients undergo
TBI on day -6. Patients receive ATG IV over at least 6 hours and
methylprednisolone IV on days -5 to -1 and fludarabine IV over 30 minutes and
cyclophosphamide IV over 30-60 minutes on days -5 to -2.
- Regimen D: Patients receive oral or IV busulfan 4 times daily on days -9 to -5,
ATG IV over at least 6 hours on days -5 to -3, and cyclophosphamide IV over 30-60
minutes on days -5 to -2.
- Cord blood transplant: All patients undergo umbilical cord blood transplantation on day
0.
- Graft-versus-host disease prophylaxis: Patients receive oral or IV cyclosporine twice
daily beginning on day -1. Patients also receive methylprednisolone IV twice daily
beginning on day 5 and continuing until at least day 28.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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