Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017589
Status:
COMPLETED
Last Update Posted:
2014-01-06
First Post:
2001-06-06
Brief Title:
Oblimersen and Gemtuzumab Ozogamicin in Treating Older Patients With Relapsed Acute Myeloid Leukemia
Sponsor:
Genta Incorporated
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Genasense Bcl-2 Antisense Combined With Mylotarg Gemtuzumab Ozogamicin in Elderly Patients With Relapsed Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2003-04
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 Monoclonal antibodies such as gemtuzumab ozogamicin can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Oblimersen may help gemtuzumab ozogamicin kill more cancer cells by making cancer cells more sensitive to the drug
PURPOSE Phase II trial to study the effectiveness of combining oblimersen and gemtuzumab ozogamicin in treating older patients who have relapsed acute myeloid leukemia
PURPOSE Phase II trial to study the effectiveness of combining oblimersen and gemtuzumab ozogamicin in treating older patients who have relapsed acute myeloid leukemia
Detailed Description:
OBJECTIVES
Determine the complete response rate of elderly patients with relapsed CD33-positive acute myeloid leukemia treated with oblimersen and gemtuzumab ozogamicin
Determine the overall response rate and duration of response of patients treated with this regimen
Determine the safety of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oblimersen IV continuously on days 1-7 and 15-22 and gemtuzumab ozogamicin IV over 2 hours on days 4 and 18
Patients are followed monthly for 6 months
PROJECTED ACCRUAL A total of 20-100 patients will be accrued for this study within 1 year
Determine the complete response rate of elderly patients with relapsed CD33-positive acute myeloid leukemia treated with oblimersen and gemtuzumab ozogamicin
Determine the overall response rate and duration of response of patients treated with this regimen
Determine the safety of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oblimersen IV continuously on days 1-7 and 15-22 and gemtuzumab ozogamicin IV over 2 hours on days 4 and 18
Patients are followed monthly for 6 months
PROJECTED ACCRUAL A total of 20-100 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| UCCRC-10928 | None | None | None |
| GENTA-GA210 | None | None | None |