A Phase I/II Study of Total Body Irradiation, Thiotepa, and Fludarabine as Conditioning for Haploidentical CD34+ Purified Peripheral Blood Stem Cell Transplants
- Determine the safety of a conditioning regimen without anti-thymocyte globulin
comprising total body irradiation, thiotepa, and fludarabine followed by
CD34-positive-selected haploidentical allogeneic peripheral blood stem cell
transplantation in young patients with life-threatening hematologic malignancies.
- Determine the risk for severe graft-vs-host disease in patients treated with this
- Determine the kinetics of immune reconstitution in patients treated with this regimen.
- Determine the risk for life-threatening infections in patients treated with this
- Conditioning regimen: Patients 7 years of age and under undergo total body irradiation
twice daily on days -9 to -7. Patients over 7 years of age undergo total body
irradiation once on day -7. All patients receive fludarabine IV once daily on days -6
to -2 and thiotepa IV over 2 hours twice on day -5.
- CD34-positive (CD34+)-selected haploidentical allogeneic peripheral blood stem cell
transplantation (PBSCT): Patients undergo CD34+-selected allogeneic PBSCT on days 0 and
Patients with acute lymphoblastic leukemia or CNS disease also receive methotrexate
intrathecally twice before transplantation and 4 times after day 35 post-transplantation.
Male patients with lymphoid malignancies undergo additional radiotherapy to the testes.
After completion of study treatment, patients are followed for at least 100 days, at 1 year,
and then periodically thereafter.
PROJECTED ACCRUAL: A total of 20 patients (10 patients ≤ 7 years of age and 10 patients > 7
years of age) will be accrued for this study within 3 years.
Masking: Open Label, Primary Purpose: Treatment
Ann E. Woolfrey, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|Seattle Cancer Care Alliance||Seattle, Washington 98109|