Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003561
Status:
TERMINATED
Last Update Posted:
2011-07-20
First Post:
1999-11-01
Brief Title:
Interferon Alfa Plus Sargramostim in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous 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 With Interferon-Alpha IFN-alpha for Chronic Myeloid Leukemia
Status:
TERMINATED
Status Verified Date:
2011-04
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 Interferon alfa may interfere with the growth of cancer cells Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of therapy Combining sargramostim with interferon alfa may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of sargramostim in treating patients who are receiving interferon alfa for chronic phase chronic myelogenous leukemia that is in remission
PURPOSE Phase II trial to study the effectiveness of sargramostim in treating patients who are receiving interferon alfa for chronic phase chronic myelogenous leukemia that is in remission
Detailed Description:
OBJECTIVES I Estimate the rate of major cytogenetic responses to sargramostim GM-CSF and interferon alfa in patients with newly diagnosed chronic phase chronic myeloid leukemia II Estimate the dosing schedule and toxic effects of GM-CSF plus interferon alfa in these patients
OUTLINE All patients are in hematologic remission on subcutaneous interferon alfa upon entering the study Once a complete hematologic response is achieved and the interferon alfa dose has been stable for 14 days patients receive subcutaneous sargramostim GM-CSF daily for 6 months Patients are followed at 3 6 9 and 12 months
PROJECTED ACCRUAL Approximately 48 patients will be accrued for this study
OUTLINE All patients are in hematologic remission on subcutaneous interferon alfa upon entering the study Once a complete hematologic response is achieved and the interferon alfa dose has been stable for 14 days patients receive subcutaneous sargramostim GM-CSF daily for 6 months Patients are followed at 3 6 9 and 12 months
PROJECTED ACCRUAL Approximately 48 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA006973 | NIH | None | None |
| JHOC-98011606 | None | None | None |
| JHOC-9806 | None | None | None |
| NCI-V98-1468 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |