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

National Cancer Institute (NCI)400 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Leukemia

Interventions

DNA methylation analysisGENETIC

RNA analysisGENETIC

gene expression analysisGENETIC

microarray analysisGENETIC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Genetic signature predictive of progression and drug resistance in AML

Secondary Outcomes

Identification of biological pathways in non-responder AML patients

Data from ClinicalTrials.gov

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