S0106B Studying Bone Marrow Samples From Women With Acute Myeloid Leukemia

Completed

• Conditions: Leukemia

• Registration Number: NCT01575535
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

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

PURPOSE: This research trial studies bone marrow samples from women with acute myeloid leukemia.

Detailed Description

OBJECTIVES:

* Estimate the proportion of acute myeloid leukemia (AMLs) that originate in CD33+ precursors or in which uncontrolled growth is limited to CD33+ precursors.

* Explore whether there is an association between the cellular origin of AML (i.e., origination in CD33+ precursors or not) and cytogenetic, molecular, and other patient characteristics.

* Explore whether overall survival (OS), event-free survival (EFS), disease-free survival (DFS), response rate (RR), or relapse rate is improved for patients with AMLs that originate in CD33+ precursors or in which uncontrolled growth is limited to CD33+ precursors compared to patients with clonally involved cells not detected.

OUTLINE: Archived bone marrow samples are analyzed for CD33+ progenitors, X-chromosome inactivation, and somatic mutations (t(8;21), inv(16), FLT3/ITD, NPM1, CEBPA, KIT) by fluorescence-activated cell sorting, long-term culture in hypoxic condition in cytokine-containing liquid media, and flow cytometry. Results are then compared with each patient clinical data.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-10
• Study First Posted: 2012-04-11
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Associations between survival outcomes (OS, EFS, DFS, RR, and relapse rate) and CD33+ restriction using regression analysis	May 2012
Association between CD33+ precursors and cytogenetic and/or molecular risks using Fisher's exact test	May 2012
Relationship between emergence of individual mutations [t(8;21), inv(16), FLT3/ITD, NPM1, CEBPA, and KIT], clonality, and stage of cell differentiation using Fisher's exact test	May 2012