Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025545
Status:
COMPLETED
Last Update Posted:
2010-05-13
First Post:
2001-10-11
Brief Title:
Filgrastim-Treated Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemiap
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase II Trial to Evaluate the Use of G-CSF-Mobilized Peripheral Blood Progenitor Cells as Hematopoietic Rescue in Patients With Acute Leukemia Undergoing Allografting From an Unrelated Donor
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 Transplanted peripheral stem cells can sometimes be rejected by the bodys tissues Treating donor peripheral stem cells with filgrastim may increase the number of donor white blood cells This may help to decrease the rejection of the transplanted cells in patients receiving them as treatment for acute leukemia
PURPOSE Phase II trial to study the effectiveness of filgrastim-treated donor peripheral stem cells in treating patients with acute leukemia who are undergoing peripheral stem cell transplantation
PURPOSE Phase II trial to study the effectiveness of filgrastim-treated donor peripheral stem cells in treating patients with acute leukemia who are undergoing peripheral stem cell transplantation
Detailed Description:
OBJECTIVES
Determine whether filgrastim G-CSF-mobilized allogeneic peripheral blood stem cell transplantation reduces the incidence of non-leukemic mortality in patients with acute leukemia
Determine the kinetics and durability of engraftment after treatment with this regimen in these patients
Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen
Determine the leukemia-free survival of patients treated with this regimen
OUTLINE Donors receive filgrastim G-CSF subcutaneously SC on days -5 to -1 Donors then undergo leukapheresis on days -1 and 0
Patients undergo total body irradiation twice daily on days -7 to -4 Patients receive 2 doses of intrathecal methotrexate per local guidelines between days -10 and -3 Patients also receive cyclophosphamide IV on days -3 and -2 Patients receive infusion of allogeneic peripheral blood stem cells on day 0
PROJECTED ACCRUAL A total of 5-60 patients will be accrued for this study within 3 years
Determine whether filgrastim G-CSF-mobilized allogeneic peripheral blood stem cell transplantation reduces the incidence of non-leukemic mortality in patients with acute leukemia
Determine the kinetics and durability of engraftment after treatment with this regimen in these patients
Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen
Determine the leukemia-free survival of patients treated with this regimen
OUTLINE Donors receive filgrastim G-CSF subcutaneously SC on days -5 to -1 Donors then undergo leukapheresis on days -1 and 0
Patients undergo total body irradiation twice daily on days -7 to -4 Patients receive 2 doses of intrathecal methotrexate per local guidelines between days -10 and -3 Patients also receive cyclophosphamide IV on days -3 and -2 Patients receive infusion of allogeneic peripheral blood stem cells on day 0
PROJECTED ACCRUAL A total of 5-60 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 |
|---|---|---|---|
| CDR0000068972 | REGISTRY | PDQ | None |
| FHCRC-109900 | None | None | None |
| NCI-H01-0078 | None | None | None |