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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 23, 2010
Last updated: August 27, 2010
Last verified: August 2010

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.

Condition Intervention
Genetic: proteomic profiling
Other: flow cytometry
Other: laboratory biomarker analysis

Study Type: Observational
Official 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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of patients achieving a complete response to induction chemotherapy

Estimated Enrollment: 200
Study Start Date: October 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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.


  • 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.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • Not specified


  • See Disease Characteristics
  Contacts and Locations
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Please refer to this study by its identifier: NCT01169363

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Elisabeth Paietta, PhD Our Lady of Mercy Medical Center
  More Information

Responsible Party: Robert L. Comis, ECOG Group Chair's Office Identifier: NCT01169363     History of Changes
Other Study ID Numbers: CDR0000681533
Study First Received: July 23, 2010
Last Updated: August 27, 2010

Keywords provided by National Cancer Institute (NCI):
adult acute myeloid leukemia in remission
recurrent adult acute myeloid leukemia
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute megakaryoblastic leukemia (M7)
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 myeloblastic leukemia without maturation (M1)
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)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms processed this record on April 24, 2017