Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072579
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2003-11-04
Brief Title:
Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Phase II Study of GM-CSF in Patients With Chronic Phase Chronic Myeloid Leukemia CP-CML Who Are Not in Complete Cytogenetic Remission After Initial Therapy
Status:
COMPLETED
Status Verified Date:
2013-06
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 Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may bring about complete remission in patients who have chronic phase chronic myelogenous leukemia
PURPOSE This phase II trial is studying sargramostim to see how well it works in treating patients with chronic phase chronic myelogenous leukemia that is not in complete cytogenetic remission after initial treatment
PURPOSE This phase II trial is studying sargramostim to see how well it works in treating patients with chronic phase chronic myelogenous leukemia that is not in complete cytogenetic remission after initial treatment
Detailed Description:
OBJECTIVES
Determine the efficacy and safety of sargramostim GM-CSF by cytogenetic examination of the bone marrow in patients with chronic phase chronic myelogenous leukemia who are not in complete cytogenetic remission after initial therapy
OUTLINE Patients receive sargramostim GM-CSF subcutaneously daily for 3 months in the absence of disease progression or unacceptable toxicity Patients achieving no response receive GM-CSF for an additional 3 months Patients failing to achieve a partial response or better after the second course of GM-CSF are removed from the study Patients achieving a partial response after the first or second course of GM-CSF continue to receive GM-CSF for an additional 9 months Patients are then re-evaluated Patients achieving a complete cytologic response at 9 months then receive GM-CSF 3 times weekly in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 weeks
PROJECTED ACCRUAL A total of 9-24 patients will be accrued for this study within 3 years
Determine the efficacy and safety of sargramostim GM-CSF by cytogenetic examination of the bone marrow in patients with chronic phase chronic myelogenous leukemia who are not in complete cytogenetic remission after initial therapy
OUTLINE Patients receive sargramostim GM-CSF subcutaneously daily for 3 months in the absence of disease progression or unacceptable toxicity Patients achieving no response receive GM-CSF for an additional 3 months Patients failing to achieve a partial response or better after the second course of GM-CSF are removed from the study Patients achieving a partial response after the first or second course of GM-CSF continue to receive GM-CSF for an additional 9 months Patients are then re-evaluated Patients achieving a complete cytologic response at 9 months then receive GM-CSF 3 times weekly in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 weeks
PROJECTED ACCRUAL A total of 9-24 patients will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-7350 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000340983 | REGISTRY | None | None |
| BRLX-02153 | None | None | None |