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

The Genetics of Non-Response in Adult AML

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01421862
Enrollment
400
Registered
2011-08-23
Start date
2011-09-30
Completion date
Unknown
Last updated
2013-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

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)

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.

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.

Interventions

GENETICDNA methylation analysis
GENETICRNA analysis
GENETICgene expression analysis
GENETICmicroarray analysis
GENETICmutation analysis
GENETICnucleic acid sequencing
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Genetic signature predictive of progression and drug resistance in AML

Secondary

MeasureTime frame
Identification of biological pathways in non-responder AML patients

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026