Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006367
Status:
COMPLETED
Last Update Posted:
2010-06-17
First Post:
2000-10-04
Brief Title:
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Myelofibrosis
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Autologous Peripheral Blood Stem Cell Mobilization and Transplantation for Myelofibrosis
Status:
COMPLETED
Status Verified Date:
2010-06
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 Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelofibrosis
PURPOSE Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelofibrosis
Detailed Description:
OBJECTIVES I Determine the ability of myeloablative chemotherapy followed by peripheral blood stem cell PBSC transplantation to restore effective marrow hematopoieses in patients with advanced idiopathic myelofibrosis or myelofibrosis secondary to other myeloproliferative disorders II Determine the ability of this regimen to palliate symptoms and prolong survival in these patients III Determine if there is evidence of clonal hematopoieses before PBSC mobilization in the PBSC product and after transplantation in these patients IV Correlate the properties of the peripheral blood before mobilization and the PBSC product with engraftment in these patients V Correlate the markers of angiogenesis with clinical parameters in these patients
OUTLINE Patients with evidence of leukemic progression receive cytoreduction therapy consisting of idarubicin IV on days 1-3 and cytarabine IV continuously over days 1-7 followed by filgrastim G-CSF subcutaneously SC daily until blood counts recover and leukapheresis is completed Patients undergo leukapheresis beginning when blood counts recover and continuing until the target number of cells are collected Patients with no evidence of leukemic progression receive filgrastim SC daily until leukapheresis is completed Patients undergo leukapheresis beginning on day 4 and continuing until the target number of cells are collected Patients receive myeloablative therapy consisting of oral busulfan every six hours on days -5 to -2 Patients with leukemic progression begin myeloablative therapy at least 28 days after completion of chemotherapy Patients receive autologous peripheral blood stem cells IV on day 0 Patients are followed at 1 month 3 months 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 10-44 patients will be accrued for this study within 2 years
OUTLINE Patients with evidence of leukemic progression receive cytoreduction therapy consisting of idarubicin IV on days 1-3 and cytarabine IV continuously over days 1-7 followed by filgrastim G-CSF subcutaneously SC daily until blood counts recover and leukapheresis is completed Patients undergo leukapheresis beginning when blood counts recover and continuing until the target number of cells are collected Patients with no evidence of leukemic progression receive filgrastim SC daily until leukapheresis is completed Patients undergo leukapheresis beginning on day 4 and continuing until the target number of cells are collected Patients receive myeloablative therapy consisting of oral busulfan every six hours on days -5 to -2 Patients with leukemic progression begin myeloablative therapy at least 28 days after completion of chemotherapy Patients receive autologous peripheral blood stem cells IV on day 0 Patients are followed at 1 month 3 months 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 10-44 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| CDR0000068240 | REGISTRY | PDQ | None |
| FHCRC-100600 | None | None | None |
| MCC-12245 | None | None | None |
| MCC-IRB-5698 | None | None | None |
| NCI-G00-1866 | None | None | None |