Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045435
Status:
COMPLETED
Last Update Posted:
2020-01-29
First Post:
2002-09-06
Brief Title:
Reduced Intensity Donor Peripheral Blood Stem Cell Transplant in Treating Patients With De Novo or Secondary Acute Myeloid Leukemia in Remission
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation From HLA Matched Related Donors for Treatment of Older Patients With De Novo or Secondary Acute Myeloid Leukemia in First Complete Remission
Status:
COMPLETED
Status Verified Date:
2020-01
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:
This phase II trial studies how well reduced intensity donor peripheral blood stem cell PBSC transplant works in treating patients with de novo or secondary acute myeloid leukemia AML in remission Giving low doses of chemotherapy such as fludarabine phosphate and total-body irradiation TBI before a donor PBSC transplant helps stop the growth of cancer cells It may also stop the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune cells and help destroy any remaining cancer cells graft-versus-tumor effect Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I To determine if a one-year disease free survival of 35 can be achieved among patients 55 years old with de novo and secondary AML in first complete remission CR1 who undergo nonmyeloablative hematopoietic stem cell transplant HSCT from human leukocyte antigen HLA identical related donors
II To determine if a day 200 nonrelapse related mortality of 15 can be achieved among patients 55 years old with de novo and secondary AML in CR1 who undergo nonmyeloablative HSCT from HLA identical related donors
OUTLINE
CONDITIONING REGIMEN Patients receive fludarabine phosphate intravenously IV on days -4 to -2 and undergo TBI on day 0
TRANSPLANT Patients undergo allogeneic PBSC transplant on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine CSP orally PO twice daily BID on days -3 to 56 with taper to day 77 Patients also receive mycophenolate mofetil MMF PO BID on days 0-27
After completion of study treatment patients are followed up on days 28 56 and 84 months 6 12 18 and 24 and then yearly for 5 years
I To determine if a one-year disease free survival of 35 can be achieved among patients 55 years old with de novo and secondary AML in first complete remission CR1 who undergo nonmyeloablative hematopoietic stem cell transplant HSCT from human leukocyte antigen HLA identical related donors
II To determine if a day 200 nonrelapse related mortality of 15 can be achieved among patients 55 years old with de novo and secondary AML in CR1 who undergo nonmyeloablative HSCT from HLA identical related donors
OUTLINE
CONDITIONING REGIMEN Patients receive fludarabine phosphate intravenously IV on days -4 to -2 and undergo TBI on day 0
TRANSPLANT Patients undergo allogeneic PBSC transplant on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine CSP orally PO twice daily BID on days -3 to 56 with taper to day 77 Patients also receive mycophenolate mofetil MMF PO BID on days 0-27
After completion of study treatment patients are followed up on days 28 56 and 84 months 6 12 18 and 24 and then yearly for 5 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 |
|---|---|---|---|
| NCI-2011-01307 | REGISTRY | CTRP Clinical Trial Reporting Program | None |