Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049179
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2002-11-12
Brief Title:
S0117 Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Study of Gemtuzumab Ozogamicin Mylotarg and Standard Dose ARA-C for Patients With Relapsed Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2015-03
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 cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die Combining gemtuzumab ozogamicin with cytarabine may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with cytarabine in treating patients who have relapsed acute myeloid leukemia
PURPOSE Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with cytarabine in treating patients who have relapsed acute myeloid leukemia
Detailed Description:
OBJECTIVES
Determine the safety and efficacy of gemtuzumab ozogamicin and cytarabine in patients with relapsed acute myeloid leukemia
Determine the frequency and severity of toxic effects of this regimen in CD33-positive patients
Determine preliminarily the prognostic significance of drug resistance phenotype cytogenetics and molecular genetic characteristics of patients treated with this regimen
OUTLINE This is a multicenter study
Induction Patients receive gemtuzumab ozogamicin IV over at least 2 hours on days 1 and 8 and cytarabine IV continuously over days 1-7
Consolidation Beginning between days 28 and 75 patients who achieve A1 bone marrow B1 peripheral blood and C1 extramedullary disease status receive one course of gemtuzumab ozogamicin and cisplatin as in induction chemotherapy
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 30-55 patients will be accrued for this study within 10-28 months
Determine the safety and efficacy of gemtuzumab ozogamicin and cytarabine in patients with relapsed acute myeloid leukemia
Determine the frequency and severity of toxic effects of this regimen in CD33-positive patients
Determine preliminarily the prognostic significance of drug resistance phenotype cytogenetics and molecular genetic characteristics of patients treated with this regimen
OUTLINE This is a multicenter study
Induction Patients receive gemtuzumab ozogamicin IV over at least 2 hours on days 1 and 8 and cytarabine IV continuously over days 1-7
Consolidation Beginning between days 28 and 75 patients who achieve A1 bone marrow B1 peripheral blood and C1 extramedullary disease status receive one course of gemtuzumab ozogamicin and cisplatin as in induction chemotherapy
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 30-55 patients will be accrued for this study within 10-28 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0117 | OTHER | None | None |