Leukemia Clinical Trial
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
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.
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
30,000/mm^3 vs at least 30,000/mm^3), 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 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.
- 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 3.75 years.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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