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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Unknown status

CT.gov ID

NCT01421862

Collaborator

(none)

400

Enrollment

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	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

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Official Title:

The Genetics of "Non-Response" in Adult AML

Study Start Date :

Sep 1, 2011

Anticipated Primary Completion Date :

Oct 1, 2011

Outcome Measures

Primary Outcome Measures

Genetic signature predictive of progression and drug resistance in AML []

Secondary Outcome Measures

Identification of biological pathways in non-responder AML patients []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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