Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052299
Status:
COMPLETED
Last Update Posted:
2012-08-27
First Post:
2003-01-24
Brief Title:
Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Gemtuzumab Ozogamicin GO Combined With Standard Intensive Chemotherapy Versus Standard Intensive Chemotherapy Alone For InductionConsolidation In Patients 61-75 Years Old With Previously Untreated AML A Randomized Phase III Trial AML-17 Of The EORTC-LG and the GIMEMA-ALWP
Status:
COMPLETED
Status Verified Date:
2012-08
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:
AML-17
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells It is not yet known if combining combination chemotherapy with monoclonal antibody therapy will kill more cancer cells
PURPOSE Randomized phase III trial to determine the effectiveness of combination chemotherapy with or without gemtuzumab ozogamicin in treating patients who have acute myeloid leukemia
PURPOSE Randomized phase III trial to determine the effectiveness of combination chemotherapy with or without gemtuzumab ozogamicin in treating patients who have acute myeloid leukemia
Detailed Description:
OBJECTIVES
Determine the antileukemic activity of standard induction chemotherapy with or without gemtuzumab ozogamicin in elderly patients with previously untreated acute myeloid leukemia
Determine the overall survival of patients treated with these regimens
Determine the rate of response disease-free survival event-free survival incidence of relapse and incidence of death of patients treated with these regimens
Determine the rate type and grade of toxicity of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to age 61-69 vs 70-75 CD33 positivity less than 5 vs 5-19 vs 20-80 vs more than 80 vs unknown initial WBC before hydroxyurea administration if needed less than 30000mm3 vs at least 30000mm3 and participating center Patients are randomized to 1 of 2 treatment arms
Arm I
Induction phase I Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15
Induction phase IIMICE regimen Beginning between days 50 and 53 patients receive mitoxantrone IV over 30 minutes on days 1 3 and 5 etoposide IV over 1 hour on days 1-3 and cytarabine IV continuously on days 1-7 Bone marrow evaluation is performed on day 29 Patients with partial remission PR receive a second course of MICE chemotherapy regimen Patients with complete remission CR after 1 or 2 courses of MICE regimen proceed to consolidation therapy Patients with progressive disease go off therapy
Consolidation Beginning within 4 weeks of documentation of CR patients receive gemtuzumab ozogamicin IV over 2 hours on day 0 idarubicin IV on days 1 3 and 5 etoposide IV over 1 hour on days 1-3 and cytarabine IV continuously on days 1-5 After at least day 30 patients receive a second consolidation course in the absence of disease progression or unacceptable toxicity
Arm II
Induction MICE regimen Patients receive mitoxantrone etoposide and cytarabine as in arm I induction Bone marrow evaluation is performed on day 29 Patients with PR receive a second course of MICE chemotherapy regimen Patients with CR after 1 or 2 courses of MICE regimen proceed to consolidation therapy Patients with progressive disease go off therapy
Consolidation Patients receive idarubicin etoposide and cytarabine as in arm I consolidation
Patients are followed monthly for 1 year every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 450 patients 225 per treatment arm will be accrued for this study within 375 years
Determine the antileukemic activity of standard induction chemotherapy with or without gemtuzumab ozogamicin in elderly patients with previously untreated acute myeloid leukemia
Determine the overall survival of patients treated with these regimens
Determine the rate of response disease-free survival event-free survival incidence of relapse and incidence of death of patients treated with these regimens
Determine the rate type and grade of toxicity of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to age 61-69 vs 70-75 CD33 positivity less than 5 vs 5-19 vs 20-80 vs more than 80 vs unknown initial WBC before hydroxyurea administration if needed less than 30000mm3 vs at least 30000mm3 and participating center Patients are randomized to 1 of 2 treatment arms
Arm I
Induction phase I Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15
Induction phase IIMICE regimen Beginning between days 50 and 53 patients receive mitoxantrone IV over 30 minutes on days 1 3 and 5 etoposide IV over 1 hour on days 1-3 and cytarabine IV continuously on days 1-7 Bone marrow evaluation is performed on day 29 Patients with partial remission PR receive a second course of MICE chemotherapy regimen Patients with complete remission CR after 1 or 2 courses of MICE regimen proceed to consolidation therapy Patients with progressive disease go off therapy
Consolidation Beginning within 4 weeks of documentation of CR patients receive gemtuzumab ozogamicin IV over 2 hours on day 0 idarubicin IV on days 1 3 and 5 etoposide IV over 1 hour on days 1-3 and cytarabine IV continuously on days 1-5 After at least day 30 patients receive a second consolidation course in the absence of disease progression or unacceptable toxicity
Arm II
Induction MICE regimen Patients receive mitoxantrone etoposide and cytarabine as in arm I induction Bone marrow evaluation is performed on day 29 Patients with PR receive a second course of MICE chemotherapy regimen Patients with CR after 1 or 2 courses of MICE regimen proceed to consolidation therapy Patients with progressive disease go off therapy
Consolidation Patients receive idarubicin etoposide and cytarabine as in arm I consolidation
Patients are followed monthly for 1 year every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 450 patients 225 per treatment arm will be accrued for this study within 375 years
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 |
|---|---|---|---|
| GIMEMA-AML-17 | None | None | None |
| EORTC-06012 | None | None | None |
| AML-17 | None | None | None |