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

Leukemia Clinical Trial

Official title:

Determining the Clinicopathological Significance of CaMKIIgamma Activation in AML

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00899743
• Other study ID #: S9333A
• Secondary ID: U10CA032102SWOG-
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: March 5, 2015
• Start date: August 2008
• Est. completion date: June 2009

Study information

• Verified date: March 2015
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 56 Years and older

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid, Acute

Intervention

Genetic:
• polyacrylamide gel electrophoresis
polyacrylamide gel electrophoresis
• western blotting
western blotting

Other:
• immunologic technique
immunologic technique
• laboratory biomarker analysis
laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of specific clinicopathological variables and outcomes with calmodulin-dependent protein kinase II-? (CaMKII?) activation (autophosphorylation)		upon receipt of specimens	No