NCT00085709
S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML
PHASE3
COMPLETED
NCT00085709
INTERVENTIONAL
A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) During Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy For Patients Under Age 61 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)
RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop cancer cells from dividing so they stop growing and die. 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. Combining chemotherapy with gemtuzumab ozogamicin may kill more cancer cells. It is not yet known whether induction therapy using cytarabine and daunorubicin is more effective with or without gemtuzumab ozogamicin or whether postconsolidation therapy using gemtuzumab ozogamicin is more effective than no additional therapy in treating de novo (first occurrence) acute myeloid leukemia.
PURPOSE: This randomized phase III trial is comparing two different regimens of chemotherapy and monoclonal antibody therapy to see how well they work in treating patients with previously untreated de novo acute myeloid leukemia.
DISEASE CHARACTERISTICS:
* Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspiration and biopsy\* within the past 14 days
* No M3 disease NOTE: \*Patients with marked leukocytosis may be registered before the availability of biopsy results if the absolute blast count is ≥ 100,000 cells/µL
* No blastic transformation of chronic myelogenous leukemia
* No pre-existing hematologic disorder evolving to AML (e.g., myelodysplasia or secondary leukemia)
PATIENT CHARACTERISTICS:
Age
* 18 to 60
Performance status
* Zubrod 0-3
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* AST and ALT ≤ 3 times ULN
* No known hepatitis B or C infection
* No known liver disease
Renal
* Not specified
Cardiovascular
* LVEF ≥ 50% by MUGA or echocardiogram
* No unstable cardiac arrhythmias
* No unstable angina
Other
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior systemic chemotherapy
* Prior hydroxyurea to control high cell counts allowed
* No more than 1 prior dose of intrathecal chemotherapy for acute leukemia
* Concurrent intrathecal chemotherapy allowed during induction therapy
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Leukemia
- TREATMENT
-
- Type: DRUG
- Name: gemtuzumab ozogamicin
- Description: Given IV, induction Arm1 6mg/m2 D4; post-consolidation 5mg/m2 3 doses \>/= 28 days apart
- Arm Group Labels: Post-consolidation GO
-
- Type: OTHER
- Name: observation
- Description: No treatment given
- Arm Group Labels: Post-consolidation observation
-
- Type: DRUG
- Name: Cytosine arabinoside
- Description: IV; induction Arms1/2 and reinduction 100 mg/m2/d days 1-7; consolidation 3gm/m2 q3hrs D1, 3, 5
- Arm Group Labels: Induction 7+3, Induction 7+3+GO
-
- Type: DRUG
- Name: Daunomycin
- Description: IV; induction Arm1 45mg/m2 D1-3; Arm2 and reinduction 60 mg/m2 D1-3;
- Arm Group Labels: Induction 7+3, Induction 7+3+GO
- SWOG Cancer Research Network