Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024050
Status:
COMPLETED
Last Update Posted:
2010-05-13
First Post:
2001-09-13
Brief Title:
Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Allogeneic Peripheral Blood Stem Cell PBSC Transplantation for the Treatment of Less Advanced Myelodysplasi
Status:
COMPLETED
Status Verified Date:
2010-05
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy
PURPOSE Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Determine the non-relapse toxicity and mortality on day 100 and at 1 year after transplantation in patients with low or intermediate-risk myelodysplastic syndrome treated with busulfan cyclophosphamide and allogeneic peripheral blood stem cell transplantation
Determine the incidence of donor stem cell engraftment and relapse-free survival in these patients treated with this regimen
Determine the incidence and severity of acute and chronic graft-versus-host disease and invasive fungal infections in these patients treated with this regimen
Determine the incidence of relapse in these patients treated with this regimen
OUTLINE Peripheral blood stem cells PBSC or bone marrow are harvested from a related or unrelated compatible donor PBSC are selected for CD34 cells
Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2 Allogeneic PBSC or bone marrow is infused on day 0
As graft-versus-host disease prophylaxis patients receive cyclosporine IV beginning on day -1 and continuing orally twice daily if feasible until day 51 followed by a taper Patients also receive methotrexate IV on days 1 3 6 and 11
Patients are followed through day 100 every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 3 years
Determine the non-relapse toxicity and mortality on day 100 and at 1 year after transplantation in patients with low or intermediate-risk myelodysplastic syndrome treated with busulfan cyclophosphamide and allogeneic peripheral blood stem cell transplantation
Determine the incidence of donor stem cell engraftment and relapse-free survival in these patients treated with this regimen
Determine the incidence and severity of acute and chronic graft-versus-host disease and invasive fungal infections in these patients treated with this regimen
Determine the incidence of relapse in these patients treated with this regimen
OUTLINE Peripheral blood stem cells PBSC or bone marrow are harvested from a related or unrelated compatible donor PBSC are selected for CD34 cells
Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2 Allogeneic PBSC or bone marrow is infused on day 0
As graft-versus-host disease prophylaxis patients receive cyclosporine IV beginning on day -1 and continuing orally twice daily if feasible until day 51 followed by a taper Patients also receive methotrexate IV on days 1 3 6 and 11
Patients are followed through day 100 every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients 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 |
|---|---|---|---|
| CDR0000068887 | REGISTRY | PDQ | None |
| FHCRC-153600 | None | None | None |
| NCI-G01-2009 | None | None | None |