Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006223
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2000-09-11
Brief Title:
flt3L in Treating Patients With Acute Myeloid Leukemia
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of Flt3 Ligand Flt3L Therapy in Acute Myeloid Leukemia AML Patients in Remission
Status:
COMPLETED
Status Verified Date:
2006-09
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 such as flt3L may stimulate a persons immune system and help kill cancer cells It is not yet known if flt3L is effective in treating acute myeloid leukemia
PURPOSE Randomized phase III trial to determine the effectiveness of flt3L in treating patients who have acute myeloid leukemia that is in remission
PURPOSE Randomized phase III trial to determine the effectiveness of flt3L in treating patients who have acute myeloid leukemia that is in remission
Detailed Description:
OBJECTIVES
Compare the failure-free survival and overall survival in patients with acute myeloid leukemia in complete remission treated with maintenance flt3 ligand vs observation alone
Compare the long-term immunologic effects of these regimens in these patients
Compare the long-term safety and toxicity of these regimens in these patients
OUTLINE This is a randomized study Patients are stratified according to complete remission CR first vs second vs third or subsequent and post-remission therapy yes vs no Patients are randomized to one of two treatment arms
Arm I Patients receive flt3 ligand subcutaneously daily on days 1-14 Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo observation alone Patients begin treatment or observation within 4 weeks after documentation of CR after induction therapy or within 4 weeks after discharge from hospital after post-remission therapy
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 139 patients will be accrued for this study within approximately 28 months
Compare the failure-free survival and overall survival in patients with acute myeloid leukemia in complete remission treated with maintenance flt3 ligand vs observation alone
Compare the long-term immunologic effects of these regimens in these patients
Compare the long-term safety and toxicity of these regimens in these patients
OUTLINE This is a randomized study Patients are stratified according to complete remission CR first vs second vs third or subsequent and post-remission therapy yes vs no Patients are randomized to one of two treatment arms
Arm I Patients receive flt3 ligand subcutaneously daily on days 1-14 Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo observation alone Patients begin treatment or observation within 4 weeks after documentation of CR after induction therapy or within 4 weeks after discharge from hospital after post-remission therapy
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 139 patients will be accrued for this study within approximately 28 months
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 |
|---|---|---|---|
| SWOG-E2998 | None | None | None |
| ECOG-2998 | None | None | None |
| CALGB-19903 | None | None | None |