Leukemia Clinical Trial
Official title:
A Phase I/II Study of Total Body Irradiation, Thiotepa, and Fludarabine as Conditioning for Haploidentical CD34+ Purified Peripheral Blood Stem Cell Transplants
RATIONALE: Chemotherapy, such as fludarabine and thiotepa, and radiation therapy may destroy
cancerous blood-forming cells (stem cells) in the blood and bone marrow. Giving healthy stem
cells from a donor whose blood closely resembles the patient's blood will help the patient's
bone marrow make new stem cells that become red blood cells, white blood cells, and
platelets.
PURPOSE: This phase I/II trial is studying the side effects of total-body irradiation,
fludarabine, and thiotepa and to see how well they work in treating young patients who are
undergoing a donor stem cell transplant for hematologic cancer.
OBJECTIVES:
Primary
- 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.
Secondary
- Determine the risk for severe graft-vs-host disease in patients treated with this
regimen.
- Determine the kinetics of immune reconstitution in patients treated with this regimen.
- Determine the risk for life-threatening infections in patients treated with this
regimen.
OUTLINE:
- 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
2.
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
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