Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011934
Status:
COMPLETED
Last Update Posted:
2014-04-17
First Post:
2001-03-03
Brief Title:
Bone Marrow Transplantation Plus Biological Therapy in Treating Patients With Chronic Myeloid Leukemia
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Granulocyte-Macrophage Colony Stimulating Factor Rhu-GM-CSF and Autologous Bone Marrow Transplantation for Chronic Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2014-04
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 Biological therapy may increase the number of immune cells found in bone marrow and may help a persons immune system recover from the side effects of the chemotherapy used in treating chronic myeloid leukemia Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy
PURPOSE Phase II trial to study the effectiveness of bone marrow transplantation chemotherapy and biological therapy in treating patients who have chronic myeloid leukemia
PURPOSE Phase II trial to study the effectiveness of bone marrow transplantation chemotherapy and biological therapy in treating patients who have chronic myeloid leukemia
Detailed Description:
OBJECTIVES I Determine the one year event-free survival in patients with chronic phase chronic myeloid leukemia receiving sargramostim GM-CSF-treated autologous bone marrow transplantation followed by GM-CSF and interferon alfa II Determine the toxicity of this regimen in these patients
OUTLINE Patients undergo harvesting of autologous bone marrow A portion of the cells are treated ex vivo with sargramostim GM-CSF for 3 days Patients then receive myeloablative chemotherapy with busulfan and cyclophosphamide on days -9 to -2 according to the preparative regimen protocol Patients undergo sargramostim GM-CSF-treated autologous bone marrow transplantation on day 0 Patients receive GM-CSF subcutaneously daily on days 5-180 and interferon alfa daily on days 90-180 Patients are followed monthly for 1 year every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 9-19 patients will be accrued for this study within 2-3 years
OUTLINE Patients undergo harvesting of autologous bone marrow A portion of the cells are treated ex vivo with sargramostim GM-CSF for 3 days Patients then receive myeloablative chemotherapy with busulfan and cyclophosphamide on days -9 to -2 according to the preparative regimen protocol Patients undergo sargramostim GM-CSF-treated autologous bone marrow transplantation on day 0 Patients receive GM-CSF subcutaneously daily on days 5-180 and interferon alfa daily on days 90-180 Patients are followed monthly for 1 year every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 9-19 patients will be accrued for this study within 2-3 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 |
|---|---|---|---|
| NCI-G01-1912 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |
| P30CA006973 | NIH | None | None |
| JHOC-J9833 | None | None | None |
| IMMUNEX-0010683 | None | None | None |
| JHOC-98051405 | None | None | None |