Biomarkers in Samples From Adult Patients With Acute Myeloid Leukemia Who Failed Existing Standard-of-Care Treatment

National Cancer Institute (NCI)

Status: Unknown

Conditions: Leukemia

Treatments: Genetic: DNA methylation analysis; Genetic: RNA analysis; Genetic: mutation analysis; Other: laboratory biomarker analysis; Genetic: gene expression analysis; Genetic: nucleic acid sequencing; Genetic: microarray analysis

Study type: Observational

Funder types: NIH

Identifiers

NCT01421862

FHCRC-9140

CDR0000709269 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: Studying samples of bone marrow and blood from patients with cancer who failed treatment may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer resistance. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies biomarkers in samples from adult patients with acute myeloid leukemia who failed standard-of-care treatment.

Full description

OBJECTIVES:

• Define a "non-response" signature that will help up-front identification of cases of intermediate-risk acute myeloid leukemia (AML) destined to fail existing standard-of-care therapy.
• Identify biological pathways in the "non-response" group that can provide targets for novel therapeutics.

OUTLINE: DNA and RNA extracted from cryopreserved bone marrow cells and/or blood cells are analyzed for mutations and gene expression signatures (genome-wide methylation, mRNA and miRNA expression, and single nucleotide polymorphism (SNP) analysis) by microarray assays.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Samples from previously untreated non-M3 acute myeloid leukemia (AML)

• Normal karyotype (NK) intermediate-risk disease

• Two or more vials of cryopreserved pretreatment bone marrow cells and/or two or more vials of cryopreserved pretreatment blood cells available from the Intergroup AML Repository

• Blast count ≥ 60%

• Eligible and evaluable for the patient's clinical trial, and did not have fatal induction toxicity

• Response to protocol induction chemotherapy:

  • Non-response: AML with failure to achieve a complete remission (CR) after induction chemotherapy ("7 & 3"-based therapy using cytatabine and/or daunorobicin hydrochloride (DNR) OR idarubicin and/or DNR
  • Responders: continued complete remission (CCR) > 2 years

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics