Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091234
Status:
UNKNOWN
Last Update Posted:
2012-07-24
First Post:
2004-09-07
Brief Title:
Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated 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 Monotherapy Versus Standard Supportive Care for Previously Untreated AML in Elderly Patients Who Are Not Eligible for Intensive Chemotherapy A Randomized Phase IIIII Trial AML-19 of the EORTC-LG and GIMEMA-ALWP
Status:
UNKNOWN
Status Verified Date:
2012-07
Last Known Status:
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:
AML-19
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 It is not yet known whether gemtuzumab ozogamicin is more effective than standard supportive care in treating older patients who have acute myeloid leukemia
PURPOSE This randomized phase IIIII trial is studying two different gemtuzumab ozogamicin regimens to see how well they work compared to standard supportive care in treating older patients with previously untreated acute myeloid leukemia
PURPOSE This randomized phase IIIII trial is studying two different gemtuzumab ozogamicin regimens to see how well they work compared to standard supportive care in treating older patients with previously untreated acute myeloid leukemia
Detailed Description:
OBJECTIVES
Compare the feasibility toxicity and antileukemic activity of two different dosing regimens of gemtuzumab ozogamicin GO vs standard supportive care in older patients with previously untreated acute myeloid leukemia who are not candidates for intensive chemotherapy phase II
Compare the efficacy and toxicity of the best dosing regimen of GO selected from phase II vs standard supportive care in terms of overall survival in these patients phase III
OUTLINE This is a randomized open-label multicenter phase II study followed by a phase III study Patients are stratified according to age 61 to 75 vs 76 to 80 vs 81 and over CD33-positivity of bone marrow blasts 20 vs 20-80 vs 80 vs unknown initial WBC before hydroxyurea administration 30000mm3 vs 30000mm3 WHO performance status 0-1 vs 2 vs 3-4 and participating center
Phase II Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive gemtuzumab ozogamicin GO IV over 2 hours on days 1 and 8 Patients with stable or responding disease at day 36 receive GO IV over 2 hours every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive GO IV over 2 hours on days 1 3 and 5 Patients with stable or responding disease at day 36 receive GO IV over 2 hours every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
Arm III Patients receive standard supportive care
Phase III Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive the selected treatment arm I or arm II from phase II
Arm II Patients receive standard supportive care Patients who receive GO treatment are followed monthly for 1 year and then every 3 months thereafter Patients who receive standard supportive care are followed at least every 4 weeks
PROJECTED ACCRUAL A total of 259 patients 75 for phase II 25 per treatment arm and 184 for phase III 92 per treatment arm will be accrued for this study within 25 years
Compare the feasibility toxicity and antileukemic activity of two different dosing regimens of gemtuzumab ozogamicin GO vs standard supportive care in older patients with previously untreated acute myeloid leukemia who are not candidates for intensive chemotherapy phase II
Compare the efficacy and toxicity of the best dosing regimen of GO selected from phase II vs standard supportive care in terms of overall survival in these patients phase III
OUTLINE This is a randomized open-label multicenter phase II study followed by a phase III study Patients are stratified according to age 61 to 75 vs 76 to 80 vs 81 and over CD33-positivity of bone marrow blasts 20 vs 20-80 vs 80 vs unknown initial WBC before hydroxyurea administration 30000mm3 vs 30000mm3 WHO performance status 0-1 vs 2 vs 3-4 and participating center
Phase II Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive gemtuzumab ozogamicin GO IV over 2 hours on days 1 and 8 Patients with stable or responding disease at day 36 receive GO IV over 2 hours every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive GO IV over 2 hours on days 1 3 and 5 Patients with stable or responding disease at day 36 receive GO IV over 2 hours every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
Arm III Patients receive standard supportive care
Phase III Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive the selected treatment arm I or arm II from phase II
Arm II Patients receive standard supportive care Patients who receive GO treatment are followed monthly for 1 year and then every 3 months thereafter Patients who receive standard supportive care are followed at least every 4 weeks
PROJECTED ACCRUAL A total of 259 patients 75 for phase II 25 per treatment arm and 184 for phase III 92 per treatment arm will be accrued for this study within 25 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 |
|---|---|---|---|
| EORTC-06031 | None | None | None |