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S9333A Study of Blood and Bone Marrow Samples From Patients With Previously Untreated Primary Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00899743
First received: May 9, 2009
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood and bone marrow samples from patients with previously untreated primary acute myeloid leukemia.


Condition Intervention
Leukemia
 Genetic: polyacrylamide gel electrophoresis
Genetic: western blotting
Other: immunologic technique
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Determining the Clinicopathological Significance of CaMKIIgamma Activation in AML

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Association of specific clinicopathological variables and outcomes with calmodulin-dependent protein kinase II-γ (CaMKIIγ) activation (autophosphorylation) [ Time Frame: upon receipt of specimens ] [ Designated as safety issue: No ]

Enrollment: 132
Study Start Date: August 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Genetic: polyacrylamide gel electrophoresis
    polyacrylamide gel electrophoresis
    Genetic: western blotting
    western blotting
    Other: immunologic technique
    immunologic technique
    Other: laboratory biomarker analysis
    laboratory biomarker analysis
Detailed Description:

OBJECTIVES:

  • Determine whether calmodulin-dependent protein kinase II-γ (CaMKIIγ) activation (autophosphorylation) is associated with specific clinicopathological variables and outcomes in blood and bone marrow samples from patients with previously untreated primary acute myeloid leukemia.

OUTLINE: Blood and bone marrow samples are analyzed by western blot using SDS-PAGE and immunoblotting using anti-calmodulin-dependent protein kinase II-γ (CaMKIIγ) and anti-phosphospecific (Thr286, 287) CaMKIIγ antibodies with signals detected via chemiluminescence. CaMKIIγ activation levels are linked to clinical variables within the SWOG database.

  Eligibility

Ages Eligible for Study:   56 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

specimens from S9333

Criteria

DISEASE CHARACTERISTICS:

  • Cryopreserved specimens of marrow or peripheral blood from patients enrolled in clinical trial SWOG-9333 and meeting the following criteria:

    • Diagnosis of primary acute myeloid leukemia

      • No M3 disease
      • Previously untreated disease
    • Randomized to remission induction chemotherapy with mitoxantrone hydrochloride and etoposide (Arm II)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899743

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven J. Collins, MD Fred Hutchinson Cancer Research 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: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00899743     History of Changes
Other Study ID Numbers: CDR0000612640, U10CA032102, SWOG-9333A
Study First Received: May 9, 2009
Last Updated: December 13, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
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 t(8;21)(q22;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
untreated adult acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013