Risk-adapted Therapy for Adult Acute Myeloid Leukemia.
Condition: Leukemia, Myelocytic, Acute
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      In a protocol of treatment of AML used in 1994 for adults with AML up to the age of 50 years,
      the Spanish CETLAM group showed a complete remission rate 75 % using the combination of
      daunorubicin (60 mg/m2, 3 days) plus conventional dose cytarabine (100mg/m2/day in continuous
      infusion during 7 days) and etoposide (100mg/m2 IV/day 3 days). If idarubicin (10 mg/m2, 3
      days) was administered instead of daunorubicin, the complete remission (CR) rate in adults up
      to 60 years was 75%. To improve the proportion of CRs and to decrease relapse rate appearing
      in 50% of patients, the phase II AML-99 trial includes intermediate dose-cytarabine during
      induction and risk-adapted post remission treatment based on the improvement in prognostic
      characterization of AML and the implementation of novel transplantation techniques.
    

Detailed description: 
      Induction chemotherapy: idarubicin (12mg/m2/day intravenous), intermediate-dose cytarabine
      (500mg/m2/12h, intravenous) and etoposide (100mg/m2/day, intravenous) in 3+7+3 schedule. This
      induction therapy is repeated if complete remission (CR) is not achieved after the first
      course of treatment.

      Consolidation therapy: mitoxantrone (12mg/m2/day, intravenous, days 4, 5 and 6) and
      intermediate-dose cytarabine (500mg/m2/12h from day 1 to 6).

      Risk-stratification according to cytogenetics, courses to CR and availability of an
      HLA-identical sibling:

        -  Patients in the favorable cytogenetics group [t(8;21), inv(16) or t(16;16)] are treated
           with high-dose cytarabine (3g/m2/12h, intravenous, days 1, 3 and 5).

        -  Patients in intermediate cytogenetics group (normal karyotype and a single course to
           achieve the CR) receive an autologous peripheral blood stem cell (PBSC) transplant,
           regardless of having an HLA-identical sibling.

        -  The remaining patients are considered in the high-risk group and are treated with
           autologous or allogeneic PBSC transplantation depending on the availability of a sibling
           donor. In allotransplants, CD34+ cell selection of hematopoietic cells is performed.
    

Intervention name(s): Ara-C; Autologous transplantation; Allogeneic HLA-identical sibling transplantation; CD34+ selection
Intervention type(s): Drug; Other; Other; Other
Intervention description(s): Intermediate dose during induction phase to remission.
High-dose during consolidation phase in patients with favorable cytogenetics.; In patients with normal karyotype and one cycle of chemotherapy to achieve complete remission.
In patients with other cytogenetics without HLA-Identical sibling.; Patients without favorable or normal karyotype(and one course to CR).
Patients with normal karyotype who need two cycles of chemotherapy to achieve CR, and other cytogenetics.; In allotransplants, it is performed a CD34+ cell selection of peripheral blood stem cell transplantation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary AML; Risk-adapted treatment; Hematopoietic transplantation; CD34+ cell selection