NCT01421862

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.

Trial Health

50
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2011

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Last Updated

July 10, 2013

Status Verified

August 1, 2011

Enrollment Period

1 month

First QC Date

August 20, 2011

Last Update Submit

July 9, 2013

Conditions

Leukemia

Keywords

adult acute basophilic leukemiaadult acute eosinophilic leukemiaadult 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) abnormalitiesadult 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 leukemiaadult acute myeloblastic leukemia without maturation (M1)adult acute megakaryoblastic leukemia (M7)

Outcome Measures

Primary Outcomes (1)

  • Genetic signature predictive of progression and drug resistance in AML

Secondary Outcomes (1)

  • Identification of biological pathways in non-responder AML patients

Interventions

DNA methylation analysisGENETIC
RNA analysisGENETIC
gene expression analysisGENETIC
microarray analysisGENETIC
mutation analysisGENETIC
nucleic acid sequencingGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

LeukemiaLeukemia, Basophilic, AcuteLeukemia, Eosinophilic, AcuteLeukemia, Erythroblastic, AcuteLeukemia, Monocytic, AcuteLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, AcuteCongenital AbnormalitiesLeukemia, Megakaryoblastic, Acute

Interventions

DNA MethylationGene Expression ProfilingMicroarray AnalysisBase Sequence

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

MethylationAlkylationBiochemical PhenomenaChemical PhenomenaMetabolismGenetic PhenomenaGenetic TechniquesInvestigative TechniquesMicrochip Analytical ProceduresMolecular StructureGenetic Structures

Study Officials

  • Jerry Radich, MD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

August 20, 2011

First Posted

August 23, 2011

Study Start

September 1, 2011

Primary Completion

October 1, 2011

Last Updated

July 10, 2013

Record last verified: 2011-08