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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Genetics of Non-Response in Adult AML

Conditions
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Leukemia

Intervention / Treatment
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* Genetic: DNA methylation analysis
* Genetic: RNA analysis
* Genetic: gene expression analysis
* Genetic: microarray analysis
* Genetic: mutation analysis
* Genetic: nucleic acid sequencing
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: DNA methylation analysis|nan|
|Genetic: RNA analysis|nan|
|Genetic: gene expression analysis|nan|
|Genetic: microarray analysis|nan|
|Genetic: mutation analysis|nan|
|Genetic: nucleic acid sequencing|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic signature predictive of progression and drug resistance in AML |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of biological pathways in non-responder AML patients |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with del(5q), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), untreated adult acute myeloid leukemia, adult acute myeloblastic leukemia without maturation (M1), adult acute megakaryoblastic leukemia (M7)