Biomarkers in Bone Marrow and Blood Samples From Older Patients With Acute Myeloid Leukemia Treated With Cytarabine-Based Therapy

RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in bone marrow and blood samples from older patients with acute myeloid leukemia treated with cytarabine-based therapy.

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Key information

Conditions

Leukemia Bone Marrow Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hematologic Diseases Hemic and Lymphatic Diseases Leukemia, Erythroblastic, Acute Leukemia, Megakaryoblastic, Acute Leukemia, Monocytic, Acute Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Acute Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

60 year–120 year

Sex eligibility

All sexes

Study type

Observational

About this study

OBJECTIVES:

Primary

To validate a pre-specified proteomic classifier to predict the likelihood of complete response (CR) to cytarabine-based induction chemotherapy in older patients with non-M3 acute myeloid leukemia.

Secondary

To identify signaling nodes associated with risk of relapse among these patients who achieve a CR to induction chemotherapy.

OUTLINE: This is a multicenter study.

Previously collected bone marrow and peripheral blood samples are analyzed to validate the association of a pre-specified proteomic signature with clinical response via flow cytometry.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

Treated on EST-1490, E-3993, or ECOG-E3999
Bone marrow and peripheral blood samples collected at diagnosis and before induction chemotherapy available
No M3 disease

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Treatment and study plan

proteomic profiling

Genetic

flow cytometry

Other

laboratory biomarker analysis

Other

Primary outcomes

Proportion of patients achieving a complete response to induction chemotherapy

Time frame: 1 month

Sponsors and collaborators

Lead sponsor

ECOG-ACRIN Cancer Research Group

Network

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

Validation of AML Proteomic Signature Associated With Clinical Response to Ara-C Based Induction Therapy in Patients 60 Years of Age or Older Using Samples From ECOG Studies 3999, 3993 and 1490

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jul 26, 2010
Registry last updated: May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed