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

NCT ID: NCT01421862

Last Updated: 2013-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

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.

Conditions

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Leukemia

Interventions

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DNA methylation analysis

Intervention Type GENETIC

RNA analysis

Intervention Type GENETIC

gene expression analysis

Intervention Type GENETIC

microarray analysis

Intervention Type GENETIC

mutation analysis

Intervention Type GENETIC

nucleic acid sequencing

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Fred Hutchinson Cancer Research Center

Principal Investigators

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Jerry Radich, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Other Identifiers

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CDR0000709269

Identifier Type: REGISTRY

Identifier Source: secondary_id

FHCRC-9140

Identifier Type: -

Identifier Source: org_study_id

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