A Randomized Phase III Study of Intensive Consolidation With High Dose Cytosine Arabinoside in Acute Myelogenous Leukemia (AML-8B)
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Patient abstract not available

      PURPOSE: Patient abstract not available
    

Detailed description: 
      OBJECTIVES: I. Assess the value (in terms of disease-free survival and overall survival) of
      short intensive consolidation with high-dose cytosine arabinoside in patients with acute
      myelogenous leukemia who achieve complete remission after induction with daunorubicin and
      cytosine arabinoside. II. Assess the toxicity and resulting quality of life associated with
      consolidation with high-dose cytosine arabinoside compared with conventional
      consolidation/maintenance treatment. III. Determine whether addition of
      granulocyte-macrophage colony stimulating factor (GM-CSF) to Induction chemotherapy can
      improve therapeutic results through activation of leukemic cells into the cell cycle and/or
      acceleration of hematopoietic recovery (objective added 08/90). IV. Determine indirectly
      whether autologous bone marrow therapy is better than conventional consolidation/maintenance
      or high-dose cytosine arabinoside by comparing results from protocol EORTC-06863 (AML 8 A).

      OUTLINE: Patients with normal kidney function are randomized on Arms A-D for Induction
      (patients whose serum creatinine is more than 1.5 x the upper limit of normal are nonrandomly
      assigned to Arm A). Following Induction, patients achieving CR are randomized to Arms I and
      II. Induction: Arm A: 2-Drug Combination Chemotherapy. Daunorubicin, Daunomycin, DNM, DNR,
      NSC-82151; Cytosine arabinoside, ARA-C, NSC-63878. Arm B: 2-Drug Combination Chemotherapy
      plus Growth Factor Therapy. DNM; ARA-C; plus Granulocyte-Macrophage Colony Stimulating Factor
      (Sandoz), GM-CSF. GM-CSF on days 0 through 7. Arm C: 2-Drug Combination Chemotherapy with
      Hematologic Toxicity Attenuation. DNM; ARA-C; GM-CSF. GM-CSF from end of chemotherapy through
      day 28. Arm D: 2-Drug Combination Chemotherapy plus Growth Factor Therapy and Hematologic
      Toxicity Attenuation. DNM; ARA-C; GM-CSF. GM-CSF on days 0 through 28. Arm I: Intensive
      Consolidation: 2-Drug Combination Chemotherapy followed by 2-Drug Combination Chemotherapy.
      High-dose ARA-C, HDARA-C; Acridinylanisidide, m-AMSA, AMSA, NSC-249992; followed by HDARA-C;
      DNR. Arm II: Standard Consolidation/Maintenance: 2-Drug Combination Chemotherapy. ARA-C; DNR.

      PROJECTED ACCRUAL: A minimum of 157 patients will be required; with an expected entry rate of
      40 patients per year, patient entry is expected to take 4 years.
    

Intervention name(s): sargramostim; amsacrine; cytarabine; daunorubicin hydrochloride; quality-of-life assessment
Intervention type(s): Biological; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Cytarabine; Daunorubicin; Amsacrine; Sargramostim
Allocation: Randomized
Primary purpose: Treatment
Keywords: untreated adult acute myeloid leukemia