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

Leukemia Clinical Trial

Official title:

The Genetics of "Non-Response" in Adult AML

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01421862
• Other study ID #: FHCRC-9140
• Secondary ID: CDR0000709269
• Status: Not yet recruiting
• Phase: N/A
• First received: August 20, 2011
• Last updated: July 9, 2013
• Start date: September 2011

Study information

• Verified date: August 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid, Acute

Intervention

Genetic:
• DNA methylation analysis

• RNA analysis

• gene expression analysis

• microarray analysis

• mutation analysis

• nucleic acid sequencing

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic signature predictive of progression and drug resistance in AML			No
Secondary	Identification of biological pathways in non-responder AML patients			No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database