Lymphoma Clinical Trial
Official title:
A Phase I Trial Of Total Body Irradiation, Cyclophosphamide Dose-Adjustment Based On Its Metabolism, And Hematopoietic Stem Cell Transplantation For Patients With Hematological Malignancy
RATIONALE: Adjusting the dose of drugs used in chemotherapy such as cyclophosphamide may
decrease side effects while stopping cancer cells from dividing so they stop growing or die.
Radiation therapy uses high-energy x-rays to damage cancer cells. Stem cell transplantation
may be able to replace immune cells that were destroyed by chemotherapy and radiation
therapy used to kill cancer cells.
PURPOSE: Phase I trial to study the effect on the body of dose-adjusted cyclophosphamide
combined with total-body irradiation and donor stem cell transplantation in treating
patients who have hematologic cancer.
OBJECTIVES:
- Determine a safe and reproducible method of adjusting the dose of cyclophosphamide
based on its metabolism when given in combination with total body irradiation and
hematopoietic stem cell transplantation in patients with hematologic malignancy.
OUTLINE:
- Preparative regimen: Patients undergo total body irradiation twice daily on days -6 to
-4. Patients then receive dose-adjusted (based on metabolism) cyclophosphamide IV over
1 hour on days -3 and -2.
- Hematopoietic stem cell (HSC) infusion: Patients undergo allogeneic HSC transplantation
on day 0.
Patients receive graft-versus-host disease prophylaxis, CNS prophylaxis, and testicular
irradiation as per institutional standard practices.
Patients are followed daily until day 80 after transplantation and then regularly thereafter
for survival.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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