Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112567
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2005-06-02
Brief Title:
Total-Body Irradiation Thiotepa and Fludarabine in Treating Young Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase III Study of Total Body Irradiation Thiotepa and Fludarabine as Conditioning for Haploidentical CD34 Purified Peripheral Blood Stem Cell Transplants
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 patients blood will help the patients bone marrow make new stem cells that become red blood cells white blood cells and platelets
PURPOSE This phase III 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
PURPOSE This phase III 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000430650 | REGISTRY | PDQ | None |
| FHCRC-162900 | None | None | None |