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Risk Adapted Treatment for Primary AML in Adults up to the Age of 60 Years.

Phase 2
18 Years
60 Years
Not Enrolling
Leukemia, Myelocytic, Acute

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Trial Information

Risk Adapted Treatment for Primary AML in Adults up to the Age of 60 Years.

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

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

- 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

- 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)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete remission rate.

Outcome Description:

Analyze the efficacy and toxicity of IDICE (idarubicin, intermediate doses of ara-C and etoposide) to achieve complete remission.

Outcome Time Frame:

2 months.

Safety Issue:


Principal Investigator

Jorge Sierra, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau


Spain: Comité Ético de Investigación Clínica

Study ID:




Start Date:

September 1998

Completion Date:

November 2003

Related Keywords:

  • Leukemia, Myelocytic, Acute
  • Primary AML
  • Risk-adapted treatment
  • Hematopoietic transplantation
  • CD34+ cell selection
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid