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The Genetics of "Non-Response" in Adult AML


N/A
18 Years
65 Years
Not Enrolling
Both
Leukemia

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Trial Information

The Genetics of "Non-Response" in Adult AML


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.

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Genetic signature predictive of progression and drug resistance in AML

Safety Issue:

No

Principal Investigator

Jerry Radich, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

Unspecified

Study ID:

CDR0000709269

NCT ID:

NCT01421862

Start Date:

September 2011

Completion Date:

Related Keywords:

  • Leukemia
  • 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)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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