Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplant in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00070135|
Recruitment Status : Completed
First Posted : October 7, 2003
Results First Posted : April 28, 2017
Last Update Posted : June 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adult Acute Myeloid Leukemia in Remission Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome||Biological: filgrastim Biological: Anti-Thymocyte Globulin Drug: busulfan Drug: fludarabine phosphate Drug: methotrexate Drug: tacrolimus Procedure: Allogeneic Hematopoietic Stem Cell Transplantation||Phase 2|
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 2004|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||June 15, 2016|
Experimental: Treatment (fludarabine, busulfan, allogeneic PBSC)
PREPARATIVE REGIMEN: Patients receive fludarabine 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.
GVHD PROPHYLAXIS: Patients receive tacrolimus PO or IV 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 PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim SC daily beginning on day 12 and continuing until blood counts recover.
Biological: Anti-Thymocyte Globulin
Drug: fludarabine phosphate
Given PO or IV
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic PBSC transplantation
Other Name: HSC, HSCT
- 2 Year Disease Free Survival In Unrelated Donor Recipient Group [ Time Frame: 2 years ]
Percentage of participants who were alive and relapse free at 2 years for patients who were matched with an unrelated donor for transplant. The 2 year disease free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.
A relapse is defined as any of the following:
- Reappearance of leukemia blasts cells in peripheral blood
- >5% blasts in the marrow, not attributable to another cause (e.g., bone marrow regeneration)
- If there are no circulating blasts, but the marrow contains 5-20% blasts, a repeat bone marrow ≥ 1 week later with >5% blasts is necessary to meet the criteria for relapse
- The development of extramedullary leukemia or leukemic cells in the cerebral spinal fluid
- 2 Year DFS for All Patients [ Time Frame: Up to 2 years ]Percentage of participants who were alive and relapse free at 2 years for all patients. The 2 year disease free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.
- Non-relapse Mortality (NRM) [ Time Frame: Up to 5 years ]Percentage of patients who died due to causes other than relapse
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070135
|Study Chair:||Steven M. Devine, MD||Ohio State University Comprehensive Cancer Center|