NCT01338974

Brief Summary

RATIONALE: Studying samples of blood and tissue from patients with cancer treated with cytarabine in the laboratory may help doctors learn more about the effects of cytarabine on cells. It may also help doctors understand how well patients respond to treatment. PURPOSE: This research trial studies biomarkers associated with response to cytarabine in samples from older patients with acute myeloid leukemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

1.4 years

First QC Date

April 19, 2011

Last Update Submit

March 5, 2015

Conditions

Leukemia

Keywords

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)recurrent adult acute myeloid leukemiauntreated adult acute myeloid leukemiaadult acute minimally differentiated myeloid leukemia (M0)adult acute myeloblastic leukemia without maturation (M1)adult acute myeloblastic leukemia with maturation (M2)adult acute myelomonocytic leukemia (M4)adult acute monoblastic leukemia (M5a)adult acute monocytic leukemia (M5b)adult erythroleukemia (M6a)adult pure erythroid leukemia (M6b)adult acute megakaryoblastic leukemia (M7)

Outcome Measures

Primary Outcomes (1)

  • Response to induction chemotherapy: complete response (CR) vs non-complete response (NR)

    1 year

Secondary Outcomes (2)

  • Complete continuous response at one year (CCR1)

    1 year

  • Relapse-free survival at one year (RFS1)

    1 year

Interventions

gene expression analysisGENETIC
proteomic profilingGENETIC
flow cytometryOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

Age56 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients enrolled on S9031, S9333, S0112 or S0301 consenting to use of specimens for future research

DISEASE CHARACTERISTICS: * Newly diagnosed with non-M3 acute myeloid leukemia (AML) * Pretreatment and relapse/refractory cryopreserved marrow and circulating mononuclear cells (MC) from patients who meet the following criteria: * Eligible and evaluable patients on study SWOG-9031, SWOG-9333 (Ara-C/DNR induction arm only), SWOG-S0112, or SWOG-S0301 * Did not refuse consent for this use of specimens * Have 2+ vials of pretreatment marrow cells and/or 2+ vials of pretreatment peripheral blood cells in the Southwest Oncology Group (SWOG) AML/MDS Repository PATIENT CHARACTERISTICS: * See Disease Characteristics 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

Related Publications (2)

  • Medeiros BC, Othus M, Fang M, Appelbaum FR, Erba HP. Cytogenetic heterogeneity negatively impacts outcomes in patients with acute myeloid leukemia. Haematologica. 2015 Mar;100(3):331-5. doi: 10.3324/haematol.2014.117267. Epub 2014 Dec 19.

    PMID: 25527568DERIVED

  • Medeiros BC, Othus M, Estey EH, Fang M, Appelbaum FR. Unsuccessful diagnostic cytogenetic analysis is a poor prognostic feature in acute myeloid leukaemia. Br J Haematol. 2014 Jan;164(2):245-50. doi: 10.1111/bjh.12625. Epub 2013 Oct 28.

    PMID: 24383844DERIVED

MeSH Terms

Conditions

LeukemiaCongenital AbnormalitiesLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, AcuteLeukemia, Monocytic, AcuteLeukemia, Erythroblastic, AcuteLeukemia, Megakaryoblastic, Acute

Interventions

Gene Expression ProfilingFlow Cytometry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesCell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, Analytical

Study Officials

  • Jerry Radich, MD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2011

First Posted

April 20, 2011

Study Start

March 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

March 6, 2015

Record last verified: 2015-03