Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027924
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
2001-12-07
Brief Title:
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Fludarabine And Busulfan As Conditioning For Patients With Chronic Myeloid Leukemia Or Myelodysplastic Syndrome Transplanted With Hematopoietic Stem Cells From HLA-Compatible Related Or Unrelated Donors
Status:
COMPLETED
Status Verified Date:
2010-03
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 Drugs used in chemotherapy use different ways to stop tumor 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 used to kill tumor cells Sometimes the transplanted cells are rejected by the bodys normal tissues Drugs such as cyclosporine may prevent this from happening
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients who have chronic myelogenous leukemia or myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients who have chronic myelogenous leukemia or myelodysplastic syndrome
Detailed Description:
OBJECTIVES I Determine the incidence of nonrelapse mortality at 100 days after allogeneic peripheral blood stem cell transplantation in patients with chronic myelogenous leukemia CML or myelodysplastic syndrome MDS treated with fludarabine and busulfan II Determine the incidence of donor stem cell engraftment in patients treated with this regimen III Determine the incidence and severity of acute graft-vs-host disease in patients treated with this regimen IV Determine the incidence of persistent or recurrent CML or MDS in patients treated with this regimen V Determine the safety of this regimen in these patients
OUTLINE Patients receive a conditioning regimen comprising fludarabine IV on days -9 to -6 and oral busulfan every 6 hours on days -5 to -2 Patients undergo allogeneic peripheral blood stem cell transplantation on day 0 Patients receive graft-vs-host disease prophylaxis comprising methotrexate IV on days 1 3 6 and 11 and cyclosporine orally or IV twice daily on days -1 to 100 followed by a taper until day 180 Patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 15 years
OUTLINE Patients receive a conditioning regimen comprising fludarabine IV on days -9 to -6 and oral busulfan every 6 hours on days -5 to -2 Patients undergo allogeneic peripheral blood stem cell transplantation on day 0 Patients receive graft-vs-host disease prophylaxis comprising methotrexate IV on days 1 3 6 and 11 and cyclosporine orally or IV twice daily on days -1 to 100 followed by a taper until day 180 Patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 15 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 |
|---|---|---|---|
| CDR0000069094 | REGISTRY | PDQ | None |
| FHCRC-151900 | None | None | None |
| NCI-H01-0082 | None | None | None |