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

NCT ID: NCT01421862

Condition: Leukemia

Conditions: Official terms:
Leukemia

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

Overall status: Unknown status

Intervention:

Intervention type: Genetic
Intervention name: DNA methylation analysis

Intervention type: Genetic
Intervention name: RNA analysis

Intervention type: Genetic
Intervention name: gene expression analysis

Intervention type: Genetic
Intervention name: microarray analysis

Intervention type: Genetic
Intervention name: mutation analysis

Intervention type: Genetic
Intervention name: nucleic acid sequencing

Intervention type: Other
Intervention name: laboratory biomarker analysis

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.

Criteria for eligibility:
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

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Start date: September 2011

Lead sponsor:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: National Cancer Institute (NCI)

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01421862

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