Biomarkers Associated With Response to Cytarabine in Samples From Older Patients With Acute Myeloid Leukemia

Biomarkers Associated With Response to Cytarabine in Samples From Older Patients With Acute Myeloid Leukemia
This study is not yet open for participant recruitment.
Verified April 2011 by National Cancer Institute (NCI)

First Received on April 19, 2011.  
Last Updated on April 26, 2011  
History of Changes
Sponsor: Southwest Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01338974
  Purpose

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 samples from older patients with acute myeloid leukemia.

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

Study Type: Observational
Official Title: Proteomic Signature Associated With Clinical Response to Cytarabine Based Induction Therapy in Patients With AML 56 Years and Older

Resource links provided by NLM:

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

Primary Outcome Measures:

  • Response to induction chemotherapy: complete response (CR) vs non-complete response (NR) [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • Complete continuous response at one year (CCR1) [ Designated as safety issue: No ]
  • Relapse-free survival at one year (RFS1) [ Designated as safety issue: No ]

Estimated Enrollment: 290
Study Start Date: March 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

  • Refinement and testing of a multiparameter flow cytometry-based cell-signaling signature (FC classifier) associated with in vivo likelihood of complete response (CR) to cytarabine-based induction chemotherapy in elderly patients (56 years and older) newly diagnosed with non-M3 acute myeloid leukemia (AML).
  • Identification of cell-signaling signature(s) associated with continuous CR to cytarabine-based induction chemotherapy at one year (CCR1) in adult patients 56 years and older with a newly diagnosed non-M3 AML.
  • Identification of cell-signaling signature(s) associated with relapse-free survival at one year (RFS1) in adult patients 56 years and older with a newly diagnosed non-M3 AML who received cytarabine-based induction chemotherapy and achieved CR.
  • To investigate changes in cell-signaling signature(s) between matched pre- and post-treatment specimens of relapsed/refractory patients.

OUTLINE: This is a multicenter study.

Cryopreserved specimens are incubated with cytokines (e.g., interleukins), growth factors (e.g., sargramostim or filgrastim), and chemotherapeutic agent (e.g., cytarabine, etoposide) and other modulators. Cells are then fixed, permeabilized, and stained with antibodies that recognize extracellular markers (for example, surface phenotypic markers such as clusters of differentiation, drug transporters, and receptors) in conjunction with intracellular activation-state-specific epitopes of designated signaling molecules. Subsequently, cell are analyzed by phospho-flow cytometry (FC) in a random manner (without knowledge of clinical variables and outcomes) to a training set (complete pre-specified FC) versus a testing set. Cells are also analyzed by proteomic assays. Results are then compared with individual patient scores, including predicted clinical outcomes.

  Eligibility

Ages Eligible for Study:   56 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01338974

Sponsors and Collaborators
Southwest Oncology Group
Investigators
Principal Investigator: Jerry Radich, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:

No publications provided

Responsible Party: Laurence H. Baker, Southwest Oncology Group – Group Chair’s Office
ClinicalTrials.gov Identifier: NCT01338974    
History of Changes
Other Study ID Numbers: CDR0000698977, SWOG-S9031-S9333-S0112-S0301-A
Study First Received: April 19, 2011
Last Updated: April 26, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):

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)
recurrent adult acute myeloid leukemia
untreated adult acute myeloid leukemia
adult 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)

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2012

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