Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006084
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2000-08-03
Brief Title:
Monoclonal Antibody in Treating Patients With Acute Myelogenous Leukemia
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Open-Label Study of HuM195 Humanized Anti-CD33 Monoclonal Antibody Administered to Patients With Acute Myelogenous Leukemia AML Who Are Documented Regimen Failures RF of the Control Arm of Study 195-301
Status:
UNKNOWN
Status Verified Date:
2001-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody in treating patients who have acute myelogenous leukemia that did not respond to standard treatment given in clinical trial PDL 195-301
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody in treating patients who have acute myelogenous leukemia that did not respond to standard treatment given in clinical trial PDL 195-301
Detailed Description:
OBJECTIVES I Determine the safety and efficacy of monoclonal antibody HuG1-M195 as demonstrated by frequency of complete remission CR in patients with acute myelogenous leukemia with regimen failure on the control arm of PDL Study 195-301 II Determine additional evidence of clinical benefit of this treatment as demonstrated by frequency of partial remission PR durations of CR and PR and progression free and overall survival in these patients
OUTLINE This is a multicenter study Patients receive monoclonal antibody HuG1-M195 MOAB HuM195 IV over 4 hours on days 1-4 every 2 weeks for 4 courses Patients without disease progression after completion of course 4 continue to receive MOAB HuM195 as above Treatment repeats every month for a maximum of 8 additional courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months
PROJECTED ACCRUAL A maximum of 100 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive monoclonal antibody HuG1-M195 MOAB HuM195 IV over 4 hours on days 1-4 every 2 weeks for 4 courses Patients without disease progression after completion of course 4 continue to receive MOAB HuM195 as above Treatment repeats every month for a maximum of 8 additional courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months
PROJECTED ACCRUAL A maximum of 100 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 |
|---|---|---|---|
| NCI-G00-1823 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016042 |
| P30CA016042 | NIH | None | None |
| UCLA-9910096 | None | None | None |
| PDL-195-302 | None | None | None |