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Biomarkers in Samples From Adult Patients With Acute Myeloid Leukemia Who Failed Existing Standard-of-Care Treatment
Conditions
Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid, Acute
Conditions: 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)
Study Type
Observational
Study Phase
N/A
Study Design
N/A
Intervention
Name: DNA methylation analysis
Type: Genetic
Name: RNA analysis
Type: Genetic
Name: gene expression analysis
Type: Genetic
Name: microarray analysis
Type: Genetic
Name: mutation analysis
Type: Genetic
Name: nucleic acid sequencing
Type: Genetic
Name: laboratory biomarker analysis
Type: Other
Overall Status
Not yet recruiting
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.
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.
- 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
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
- 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
Location
Start Date
September 2011
Sponsors
National Cancer Institute (NCI)
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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