Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia (AML-17)
|ClinicalTrials.gov Identifier: NCT00052299|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 27, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: cytarabine Drug: etoposide Drug: gemtuzumab ozogamicin Drug: idarubicin Drug: mitoxantrone hydrochloride||Phase 3|
- 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 30,000/mm^3 vs at least 30,000/mm^3), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Induction (phase I): Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15.
- Induction (phase II/MICE 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.
- 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 3.75 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||472 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gemtuzumab Ozogamicin (GO) Combined With Standard Intensive Chemotherapy Versus Standard Intensive Chemotherapy Alone For Induction/Consolidation 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|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||February 2012|
Experimental: ARM A
GO + MICE for remission induction followed by GO + mini-ICE for consolidation
|Drug: cytarabine Drug: etoposide Drug: gemtuzumab ozogamicin Drug: idarubicin Drug: mitoxantrone hydrochloride|
Active Comparator: ARM B
MICE for remission induction followed by mini-ICE for consolidation
|Drug: cytarabine Drug: etoposide Drug: idarubicin Drug: mitoxantrone hydrochloride|
- Overall survival
- Response (complete remission [CR] or complete remission with incomplete recovery of platelet count [CRp]) rate after induction
- Disease-free survival after CR/CRp
- Incidence of relapse after CR/CRp
- Incidence of death without relapse after CR/CRp
- Event-free survival
- Toxicity (highest grade) assessed by International Working Group CTC v2.0
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00052299
Show 55 Study Locations
|Study Chair:||Sergio Amadori, MD||Azienda Ospedallera Universitaria - Policlinico Tor Vergata, Roma|