S8809-S9800-S9911TM- Biological Markers in Patients With Follicular Lymphoma Treated on Clinical Trial SWOG-8809, SWOG-9800, or SWOG-9911

Lymphoma Clinical Trial

Official title:

Assessment of MUM1 Expression, Lymphoma-Associated Macrophages, and Regulatory T-Cells in Follicular Lymphoma: Prognostic Markers in SWOG S8809 and S9800/S9911 Trials Representing Pre-and Post-Monoclonal Antibody Therapy Protocols

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896922
• Other study ID #: CDR0000530630
• Secondary ID: SWOG-S8809/S9800
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: February 24, 2017
• Start date: January 2007
• Est. completion date: October 2009

Study information

• Verified date: February 2017
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.

PURPOSE: This laboratory study is examining biological markers in patients with follicular lymphoma treated on clinical trial SWOG-8809, SWOG-9800, or SWOG-9911.

Description:

OBJECTIVES:

• Determine the prognostic significance of MUM-1, lymphoma-associated macrophages, and regulatory T cells in patients with follicular lymphoma treated on clinical trials SWOG-8809, SWOG-9800, or SWOG-9911 representing pre- and post-monoclonal antibody therapy protocols.

• Determine whether these factors have similar prognostic significance in patients treated with chemotherapy alone vs chemotherapy and monoclonal antibody therapy on these clinical trials.

OUTLINE: This is a multicenter study.

Previously collected tissue samples from patients are analyzed by immunohistochemistry, gene expression profiling, and quantitative analysis for MUM1 expression, lymphoma-associated macrophages, FOXP3-positive regulatory T cells, CD68, and CD163.

PROJECTED ACCRUAL: A total of 318 samples will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of follicular lymphoma

• Previously treated on any of the following clinical trials:

• SWOG-8809

• SWOG-9800

• SWOG-9911

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Intervention

Genetic:
• microarray analysis

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

References & Publications (2)

Sweetenham JW, Goldman B, LeBlanc ML, Cook JR, Tubbs RR, Press OW, Maloney DG, Fisher RI, Rimsza LM, Braziel RM, Hsi ED. Prognostic value of regulatory T cells, lymphoma-associated macrophages, and MUM-1 expression in follicular lymphoma treated before an — View Citation

Sweetenham JW, Hsi E, Goldman B, et al.: Numbers of lymphoma associated macrophages (LAMS) and regulatory T-cells (Tregs) in follicular lymphoma (FL) patients (pts) treated with and without monoclonal antibody (MoAb)-containing therapy do not correlate wi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognostic significance of MUM-1, lymphoma-associated macrophages, and regulatory T cells		Retrospective
Primary	Comparison of prognostic significance in patients treated with chemotherapy alone vs chemotherapy and monoclonal antibody therapy		Retrospective