Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance

Inclusion Criteria:

- Age 18-60 years.

- Considered to be suitable intensive (cytotoxic) induction candidates.

- Has previously untreated, de novo, non-M3 AML with intermediate-risk disease
(Intermediate-I or Intermediate-II) as defined by ELN criteria OR normal cytogenetics
with mutated NPM1 without FLT3-ITD. Monoallelic CEBPA mutations are not considered
favorable risk and are therefore eligible.

- Has undergone cytotoxic induction therapy

- In a morphologic complete remission with incomplete blood count recovery, or
morphologic complete remission post-induction after no more than 2 induction cycles as
defined by revised IWG criteria

- Patients at Washington University must be enrolled in HRPO# 201011766 ("Tissue
Acquisition for Analysis of Genetic Progression Factors in Hematologic Diseases").This
is not a requirement for secondary sites. However, secondary sites must provide
informed consent forms that document that permission for whole genome, whole exome,
and/or genome wide sequencing, and data sharing among institutions, was obtained.
Because we will be also be sequencing non-diseased (normal) tissue, the informed
consent forms must explicitly ask if patients wish to be informed, (or in the case of
their death, their next-of-kin) if a deleterious mutation is identified in their
non-diseased tissue, as this may be heritable.

- Women of childbearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control, abstinence) prior to study entry and for
the duration of study participation. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she must inform her treating physician
immediately.

- Able to understand and willing to sign an IRB approved written informed consent
document.

- Willing to comply with the treatment assignment:

- Intent to proceed with HiDAC consolidation for LAM VAF <2.5%

- Intent to proceed with either HiDAC consolidation or allogeneic stem cell
transplantation, at the discretion of the treating physician, for LAM ≥2.5%

Exclusion Criteria:

- Diagnosis acute promyelocytic leukemia (APL) with t(15;17)(q22;q12); PML-RARA.

- Therapy-related AML (defined as occurrence of AML due to prior exposure to
chemotherapy or radiation for malignancy).

- Secondary AML (defined as development of AML in patients with an antecedent
hematological malignancy).

- Has a medical or psychosocial conditions that would prevent study compliance.

- Known seropositivity for or active viral infection with human immunodeficiency virus
(HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients who are
seropositive because of hepatitis B vaccine are eligible.

- History of allergic reaction to compounds of similar chemical or biologic composition
to cytarabine.

- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative
pregnancy test within 3 days of signing consent.