Total-Body Irradiation, Thiotepa, and Fludarabine in Treating Young Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer
|ClinicalTrials.gov Identifier: NCT00112567|
Recruitment Status : Completed
First Posted : June 3, 2005
Last Update Posted : September 21, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes||Drug: fludarabine phosphate Drug: thiotepa Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy||Phase 1 Phase 2|
- 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 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2003|
|Estimated Study Completion Date :||July 2007|
- Risk of severe graft-versus-host disease
- Kinetics of immune reconstitution
- Risk of life-threatening infections
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112567
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98104|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109-1023|
|Principal Investigator:||Ann E. Woolfrey, MD||Fred Hutchinson Cancer Research Center|