S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML
Condition: Leukemia
MeSH terms: Leukemia
Intervention: gemtuzumab ozogamicin; observation; Cytosine arabinoside; Daunomycin
Intervention description: Given IV, induction Arm1 6mg/m2 D4; post-consolidation 5mg/m2 3 doses >/= 28 days apart; No treatment given; IV; induction Arms1/2 and reinduction 100 mg/m2/d days 1-7; consolidation 3gm/m2 q3hrs D1, 3, 5; IV; induction Arm1 45mg/m2 D1-3; Arm2 and reinduction 60 mg/m2 D1-3;
Intervention MeSH terms: Cytarabine; Daunorubicin; Gemtuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 637.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: untreated adult acute myeloid leukemia; adult acute eosinophilic leukemia; adult acute basophilic leukemia; adult acute monocytic leukemia (M5b); adult acute erythroid leukemia (M6); adult acute megakaryoblastic leukemia (M7); adult acute minimally differentiated myeloid leukemia (M0); adult acute myeloblastic leukemia with maturation (M2); adult acute myeloblastic leukemia without maturation (M1); adult acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22)

Summary:

      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.
    

Eligibility criteria:

        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