Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005866
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2000-06-02
Brief Title:
S9920 Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase III Randomized Study Comparing Busulfan-Total Body Irradiation Versus Cyclophosphamide-Total Body Irradiation Preparative Regimen in Patients With Advanced Myelodysplastic Syndrome MDS or MDS-Related Acute Myeloid Leukemia AML Undergoing HLA-Identical Sibling Peripheral Blood Stem Cell Transplantation A BMT Study
Status:
COMPLETED
Status Verified Date:
2015-03
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 Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells It is not yet known if total-body irradiation plus peripheral stem cell transplantation is more effective with busulfan or with cyclophosphamide for myelodysplastic syndrome or acute myeloid leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of busulfan with that of cyclophosphamide in patients undergoing total-body irradiation plus peripheral stem cell transplantation for advanced myelodysplastic syndrome or related acute myeloid leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of busulfan with that of cyclophosphamide in patients undergoing total-body irradiation plus peripheral stem cell transplantation for advanced myelodysplastic syndrome or related acute myeloid leukemia
Detailed Description:
OBJECTIVES I Compare event free survival after total body irradiation TBI plus busulfan versus TBI plus cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation in patients with advanced myelodysplastic syndrome MDS or MDS related acute myeloid leukemia II Determine the distribution of pharmacokinetic parameters for busulfan in those patients randomized to the busulfan treatment arm III Investigate the prognostic significance for event free survival of prior history of red cell transfusions cytogenetic pattern and of functional drug resistance at diagnosis in these patients IV Estimate the frequencies of cytogenetic and genetic changes during disease progression in these patients
OUTLINE This a randomized multicenter study Patients are stratified according to age 40 and under vs 41-55 and diagnosis and International Prognostic Scoring System IPSS risk group myelodysplastic syndrome MDSIPSS - intermediate 1 vs MDSIPSS - intermediate 2 vs MDSIPSS high risk vs MDS related acute myeloid leukemia Patients are randomized to one of two treatment arms Arm I Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 for a total of 16 doses Arm II Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 Patients receive total body irradiation TBI twice a day on days -3 to -1 peripheral blood stem cell transplantation from genotypically HLA identical sibling on day 0 cyclosporine IV every 12 hours on days -1 to 60 and then tapering in the absence of graft versus host disease and methotrexate IV on days 1 3 6 and 11 Patients are followed every 6 months for 5 years
PROJECTED ACCRUAL A total of 240 patients 120 per treatment arm will be accrued for this study over 5 years
OUTLINE This a randomized multicenter study Patients are stratified according to age 40 and under vs 41-55 and diagnosis and International Prognostic Scoring System IPSS risk group myelodysplastic syndrome MDSIPSS - intermediate 1 vs MDSIPSS - intermediate 2 vs MDSIPSS high risk vs MDS related acute myeloid leukemia Patients are randomized to one of two treatment arms Arm I Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 for a total of 16 doses Arm II Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 Patients receive total body irradiation TBI twice a day on days -3 to -1 peripheral blood stem cell transplantation from genotypically HLA identical sibling on day 0 cyclosporine IV every 12 hours on days -1 to 60 and then tapering in the absence of graft versus host disease and methotrexate IV on days 1 3 6 and 11 Patients are followed every 6 months for 5 years
PROJECTED ACCRUAL A total of 240 patients 120 per treatment arm will be accrued for this study over 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S9920 | OTHER | None | None |