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Risk Adapted Treatment for Primary AML in Adults, Based on Genetics and Minimal Residual Disease (MRD) in Patients up to the Age of 70 Years.

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

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Trial Information

Risk Adapted Treatment for Primary AML in Adults, Based on Genetics and Minimal Residual Disease (MRD) in Patients up to the Age of 70 Years.

Induction chemotherapy: idarubicin (12mg/m2/day intravenous, days 1, 3 and 5),
intermediate-dose cytarabine (500mg/m2/12h, intravenous, days 1, 3 and 5) and etoposide
(100mg/m2/day, intravenous, from day 1 to 3) as in AML-99 trial (NCT01716793), with the
addition of subcutaneous G-CSF from day 0 to the last day of chemotherapy. This induction
therapy is repeated if complete remission (CR) is not achieved after the first course of

Consolidation therapy (as in AML-99 trial): mitoxantrone (12mg/m2/day, intravenous, days 4
to 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)] and
Leukocyte index <20 at diagnosis (LI=white blood cell count (WBC) x (blasts in bone
marrow/100) are treated with one course of high-dose cytarabine (3g/m2/12h,
intravenous, days 1, 3 and 5), but in case of LI>20 at diagnosis the intention is to
perform an autologous peripheral blood stem cell (PBSC) transplantation.

- Patients in intermediate risk group, with normal karyotype, a single course of
induction chemotherapy to achieve the CR, the absence of adverse molecular features
(FLT3-ITD or MLL-PTD) and low minimal residual disease levels after consolidation
(MRD<0,1%) receive an autologous PBSC transplant, regardless of having an HLA-identical

- The remaining patients defined as high-risk patients are treated with an allogeneic
stem cell transplantation. Depending on the age, if the patient has an HLA-identical
sibling donor, up to age of 50 years old it is performed with conventional conditioning
therapy and positive selection of CD34+, older patients receive a reduced intensity
conditioning regimen.

- Very high risk patients without a sibling are allocated to unrelated donor (9-10/10).
Patients with adverse cytogenetics and/or FLT3-ITD without an adequate donor received
Mylotargâ„¢ as "in vivo purging" followed by an autologous PBSC transplantation.

Inclusion Criteria:

- Patients with newly diagnosed AML, classified using OMS criteria.

- Patients with 70 years old or younger.

Exclusion Criteria:

- Patients previously treated for the AML with chemotherapy different from hidroxiurea.

- Acute promyelocytic leukemia with t(15;17).

- Cronic mieloid leukemia in blastic crisis.

- Leukemias that appear after other myeloproliferative processes.

- Leukemias that survive after myelodysplasic syndromes of more than 6 months of

- Presence of other neoplasic disease in activity.

- Secondary AML which appears after cured malignant disease (for instance, Hodgking
disease), and those who are still exposed to alkilant agents or radiation.

- Abnormal renal and hepatic functions with creatinin and/or bilirrubine 2 times higher
than the normal threshold, except when the alteration should be attributed to the

- Patient with an ejection fraction below 40%, symptomatic cardiac deficiency or both.

- Patients with neurological or concomitant psychiatric disease.

- Positivity by HIV.

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 (CRR)

Outcome Description:

Analyze the efficacy and toxicity of IDICE-G (idarubicin, intermediate doses of ara-C and etoposide) and G-CSF 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: Departament de Salut de la Generalitat de Catalunya

Study ID:




Start Date:

October 2003

Completion Date:

March 2012

Related Keywords:

  • Leukemia, Myelocytic, Acute
  • Leukemia
  • Myeloid
  • Acute
  • Young
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Neoplasm, Residual