Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006122
Status:
COMPLETED
Last Update Posted:
2012-07-16
First Post:
2000-08-03
Brief Title:
Gemtuzumab Ozogamicin With or Without Chemotherapy 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 CMA-676 Followed or Not by Intensive Chemotherapy as Initial Treatment for Elderly Patients With Acute Myeloid Leukemia An EORTC-LG Pilot Phase II Study
Status:
COMPLETED
Status Verified Date:
2012-07
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 uses different ways to stop cancer cells from dividing so they stop growing or die Combining gemtuzumab ozogamicin with chemotherapy may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of gemtuzumab ozogamicin with or without chemotherapy in treating older patients who have acute myeloid leukemia
PURPOSE Phase II trial to study the effectiveness of gemtuzumab ozogamicin with or without chemotherapy in treating older patients who have acute myeloid leukemia
Detailed Description:
OBJECTIVES I Determine the feasibility toxicity and antileukemic activity of gemtuzumab ozogamicin CMA-676 with or without mitoxantrone etoposide cytarabine and idarubicin in elderly patients with acute myeloid leukemia
OUTLINE This is a multicenter study Patients are stratified according to risk standard risk defined as age 61-75 and WHO performance status 0-1 vs poor risk defined as over 75 years and WHO performance status 0-2 OR under 76 years and WHO performance status 2 Frontline therapy Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15 Stratum I Standard risk patients Patients with disease progression at any time during frontline therapy may begin induction therapy immediately Induction therapy begins 7-10 days after response assessment regardless of response and in the absence of unacceptable toxicity Stratum II Poor risk patients Patients experiencing complete remission with or without platelet recovery will begin consolidation therapy within 4-8 weeks of response assessment in the absence of unacceptable toxicity Stratum I Induction therapy 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 Patients experiencing partial response are given a second induction therapy course Patients experiencing complete remission with or without platelet recovery after 1 or 2 induction courses begin consolidation therapy within 4-8 weeks of response assessment in the absence of unacceptable toxicity Consolidation therapy Patients receive 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 Stratum II Consolidation therapy Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 and then 1-3 months later Patients are followed monthly for 1 year every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 45-82 28-49 for stratum I and 17-33 for stratum II patients will be accrued for this study
OUTLINE This is a multicenter study Patients are stratified according to risk standard risk defined as age 61-75 and WHO performance status 0-1 vs poor risk defined as over 75 years and WHO performance status 0-2 OR under 76 years and WHO performance status 2 Frontline therapy Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15 Stratum I Standard risk patients Patients with disease progression at any time during frontline therapy may begin induction therapy immediately Induction therapy begins 7-10 days after response assessment regardless of response and in the absence of unacceptable toxicity Stratum II Poor risk patients Patients experiencing complete remission with or without platelet recovery will begin consolidation therapy within 4-8 weeks of response assessment in the absence of unacceptable toxicity Stratum I Induction therapy 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 Patients experiencing partial response are given a second induction therapy course Patients experiencing complete remission with or without platelet recovery after 1 or 2 induction courses begin consolidation therapy within 4-8 weeks of response assessment in the absence of unacceptable toxicity Consolidation therapy Patients receive 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 Stratum II Consolidation therapy Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 and then 1-3 months later Patients are followed monthly for 1 year every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 45-82 28-49 for stratum I and 17-33 for stratum II 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 |
|---|---|---|---|
| EORTC-06993-AML-15 | None | None | None |