Risk-adapted Therapy for Adult Acute Myeloid Leukemia.
Risk Adapted Treatment for Primary AML in Adults up to the Age of 60 Years.
  • Phase

    Phase 2
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

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.
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.
Study Started
Sep 30
Primary Completion
Sep 30
Study Completion
Nov 30
Last Update
Nov 01

Drug Ara-C

Intermediate dose during induction phase to remission. High-dose during consolidation phase in patients with favorable cytogenetics.

Other Autologous transplantation

In patients with normal karyotype and one cycle of chemotherapy to achieve complete remission. In patients with other cytogenetics without HLA-Identical sibling.

Other Allogeneic HLA-identical sibling transplantation

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.

Other CD34+ selection

In allotransplants, it is performed a CD34+ cell selection of peripheral blood stem cell transplantation.

Risk-adapted postremission treatment Other

Ara-C, autologous transplantation, Allogeneic HLA-identical sibling transplantation depending on risk factors (cytogenetics, courses to CR)and availability of an HLA-identical sibling, CD34+ selection.


Inclusion Criteria:

Patients with newly diagnosed AML, classified by FAB criteria
Age not superior to 60 years
Verbal informed consent for the chemotherapy and written for the mobilization and stem cell transplantation

Exclusion Criteria:

Patients treated previously for its AML with other chemotherapy different from hydroxyurea
Acute promyelocytic leukemia (M3)
Chronic myeloid leukemia in blastic crisis
Leukemias appearing after other myeloproliferative processes
Leukemias surviving after myelodysplastic syndromes with more than 6 months of evolution
Presence of other neoplastic disease in activity
Secondary AML which had appeared after cured malignancies (for instance Hodgkin disease) and those who are still exposed to alkylant agents or radiation
Renal and hepatic abnormal function with creatinine values and/or bilirubin two times higher than the normal threshold, except when this alteration could be attributed to the leukemia
Patients with a fraction of ejection very low (inferior to 40%), symptomatic cardiac insufficiency or both
Patients with a grave concomitant neurological or psychiatric disease
Positivity of HIV (donor and/or receptor)
No Results Posted