S0106B Studying Bone Marrow Samples From Women With Acute Myeloid Leukemia

Leukemia Clinical Trial

Official title:

S0106B, Stem Cell Origin in AML: Prognostic and Therapeutic Implications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575535
• Other study ID #: S0106B
• Secondary ID: S0106BU10CA03210
• Status: Completed
• Phase: N/A
• First received: April 10, 2012
• Last updated: March 5, 2015
• Start date: April 2012
• Est. completion date: May 2012

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnostic bone marrow specimens from female patients with untreated AML undergoing intensive ("3+7"-like) induction chemotherapy

• Specimens from the South Western Oncology Group (SWOG) protocols S0106 (age 18 to 60 years), excluding patients who received gemtuzumab ozogamicin (GO), and S9333 (age > 60 years)

PATIENT CHARACTERISTICS:

• See Disease Characteristics

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid, Acute

Intervention

Genetic:
• gene expression analysis

Other:
• flow cytometry

• fluorescence activated cell sorting

• laboratory biomarker analysis

• medical chart review

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 between CD33+ precursors and cytogenetic and/or molecular risks using Fisher's exact test		May 2012	No
Primary	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	No
Primary	Associations between survival outcomes (OS, EFS, DFS, RR, and relapse rate) and CD33+ restriction using regression analysis		May 2012	No