Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070135
Status:
COMPLETED
Last Update Posted:
2018-06-12
First Post:
2003-10-03
Brief Title:
Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplant in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study Of Allogeneic Transplant For Older Patients With AML In First Morphologic Complete Remission Using A Non-Myeloablative Preparative Regimen
Status:
COMPLETED
Status Verified Date:
2018-05
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 fludarabine and busulfan followed by a donor allogeneic stem cell transplant work in treating older patients with acute myeloid leukemia that is in first complete remission Giving low doses of chemotherapy such as fludarabine and busulfan before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow including normal blood-forming cells stem cells and cancer cells It may also stops the patients immune system from rejecting the donors stem cells When the healthy stem cells from a donor are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets The donated stem cells may replace the patients immune system and help destroy any remaining cancer cells Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells called graft-versus-host disease Giving tacrolimus methotrexate and rabbit antithymocyte globulin before or after the transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I Determine if allogeneic transplantation from a matched sibling or unrelated donor using a non-myeloablative preparative regimen results in a 2-year disease-free survival DFS that is better than historical results using standard chemotherapy
SECONDARY OBJECTIVES
I Determine 2-year actuarial risks of transplant-related mortality acute and chronic graft-versus-host GVHD disease and relapse among patients with acute myeloid leukemia AML in first complete remission CR1 following a non-myeloablative preparative regimen
II To examine recovery of T and B cell number and function following non-myeloablative stem cell transplant
III To examine the time course of T B and myeloid progenitor chimerism following this preparative regimen
IV To characterize the pharmacokinetics of intravenous busulfan used in a non-myeloablative preparation regimen in AML patients age 60 years
OUTLINE
PREPARATIVE REGIMEN Patients receive fludarabine intravenously IV over 30 minutes on days -7 to -3 and busulfan IV over 2 hours 4 times per day every 6 hours on days -4 and -3
GRAFT-VERSUS-HOST DISEASE GVHD PROPHYLAXIS Patients receive tacrolimus orally PO or IV twice daily BID on days -2 with taper between days 90-120 and stopping by days 150-180 Patients also receive methotrexate IV on days 1 3 6 and 11 and rabbit antithymocyte globulin IV over 4-6 hours on days -4 through -2
ALLOGENEIC PERIPHERAL BLOOD STEM CELL TRASNPLANTATION PBSC Patients undergo allogeneic PBSC transplant on day 0 Patients then receive filgrastim subcutaneously SC daily beginning on day 12 and continuing until blood counts recover
Patients are followed monthly for 1 year every 3 months for 1 year and then every 6 months for 3 years
I Determine if allogeneic transplantation from a matched sibling or unrelated donor using a non-myeloablative preparative regimen results in a 2-year disease-free survival DFS that is better than historical results using standard chemotherapy
SECONDARY OBJECTIVES
I Determine 2-year actuarial risks of transplant-related mortality acute and chronic graft-versus-host GVHD disease and relapse among patients with acute myeloid leukemia AML in first complete remission CR1 following a non-myeloablative preparative regimen
II To examine recovery of T and B cell number and function following non-myeloablative stem cell transplant
III To examine the time course of T B and myeloid progenitor chimerism following this preparative regimen
IV To characterize the pharmacokinetics of intravenous busulfan used in a non-myeloablative preparation regimen in AML patients age 60 years
OUTLINE
PREPARATIVE REGIMEN Patients receive fludarabine intravenously IV over 30 minutes on days -7 to -3 and busulfan IV over 2 hours 4 times per day every 6 hours on days -4 and -3
GRAFT-VERSUS-HOST DISEASE GVHD PROPHYLAXIS Patients receive tacrolimus orally PO or IV twice daily BID on days -2 with taper between days 90-120 and stopping by days 150-180 Patients also receive methotrexate IV on days 1 3 6 and 11 and rabbit antithymocyte globulin IV over 4-6 hours on days -4 through -2
ALLOGENEIC PERIPHERAL BLOOD STEM CELL TRASNPLANTATION PBSC Patients undergo allogeneic PBSC transplant on day 0 Patients then receive filgrastim subcutaneously SC daily beginning on day 12 and continuing until blood counts recover
Patients are followed monthly for 1 year every 3 months for 1 year and then every 6 months for 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 |
|---|---|---|---|
| U10CA180821 | NIH | NCI Clinical Trial Reporting Program | httpsreporternihgovquickSearchU10CA180821 |
| CDR0000330001 | REGISTRY | None | None |
| NCI-2009-00438 | REGISTRY | None | None |