Feasibility Study of Intermediate Doses of ARA-C With Autologous SCT as Consolidation of Low/Intermediate-risk AML

Create a network of institutions in developing countries that will perform AML diagnosis, risk classification, treatment, supportive care and follow-up evaluation according to a common protocol and will register data using common clinical research forms (CRFs) in a single database and available on the internet.

Sex

All

Minimum age

18 Years

Maximum age

65 Years

Inclusion Criteria:

1. Acute myeloid leukemia (AML) diagnosis according to WHO criteria;
2. AML not treated previously, including: de novo AML or secondary to myelodysplastic syndromes;
3. Absence of t(15;17), or PML-RARA rearrangement and its variants (acute promyelocytic leukemia diagnosis);
4. Age greater than or equal to 18 years old or lower than or equal to 65 years old;
5. Functional status ECOG from 0 to 2;
6. Signed informed consent;
7. Ability to follow the protocol procedures;
8. Willingness to use birth control methods during the treatment until its conclusion;
9. Adequate renal and liver function:

   * Bilirubin ≤ 1.5x the upper limit of normality;
   * AST and ALT ≤ 2.5x the upper limit of normality;
   * Creatinine ≤ 2.5 mg/dL.
10. Suitable cardiac function: left ventricular ejection fraction ≥ 50%.

Exclusion Criteria:

1. Acute promyelocytic leukemia (APL) diagnosis according to WHO criteria;
2. Diagnosis of acute leukemia of ambiguous lineage, biphenotypic acute leukemia or undifferentiated acute leukemia, according to WHO criteria;
3. AML previously treated, except with hydroxyurea administration for cytoreduction;
4. Age greater than 65 years old or lower than 18 years old;
5. Functional status ECOG greater than 2;
6. Do not sign the informed consent;
7. Inability to follow the protocol procedures;
8. Be fertile female who are unwilling to take any birth control method during the treatment;
9. Hypersensitivity to any drug of the treatment protocol;
10. Positive serology for HIV;
11. Altered liver and renal function not related to the primary disease (AML):

    * Bilirubin \> 1.5x the upper limit of normality
    * AST and ALT \> the 2.5x upper limit of normality
    * Creatinine \> 2.5 mg/dL

n) Altered cardiac function, with LVEF \<50%

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