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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 because the information has not been verified recently.
Verified August 2010 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01169363
First received: July 23, 2010
Last updated: August 27, 2010
Last verified: August 2010
History of Changes
  Purpose

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
Leukemia
 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:

Drug Information available for: Cytarabine
U.S. FDA Resources

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

Primary Outcome Measures:
  • Proportion of patients achieving a complete response to induction chemotherapy [ Designated as safety issue: No ]

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

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169363

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT01169363     History of Changes
Other Study ID Numbers: CDR0000681533, ECOG-E1L09T1
Study First Received: July 23, 2010
Last Updated: August 27, 2010
Health Authority: Unspecified

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
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013