To hear about similar clinical trials, please enter your email below
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
