Study of Blood and Tissue Samples From Patients With Aggressive Non-Hodgkin B-Cell Lymphoma or Hodgkin Lymphoma

Lymphoma Clinical Trial

Official title:

Evaluation of Serum Free Light Chains and Clonal Ig DNA in Plasma From Patients With Aggressive B-Cell Lymphomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981097
• Other study ID #: AMC-064
• Secondary ID: U01CA121947CDR00
• Status: Completed
• Start date: August 2009
• Est. completion date: June 2013

Study information

• Verified date: August 2020
• Source: AIDS Malignancy Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying samples of blood and tissue 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 tissue samples from patients with aggressive non-Hodgkin B-cell lymphoma or Hodgkin lymphoma.

Description:

OBJECTIVES:

Primary

• To estimate the proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC).

• To estimate the proportion of patients with Hodgkin lymphoma with clonal immunoglobulin (Ig) DNA detection in the plasma.

Secondary

• To estimate the agreement between the detection of a monoclonal Ig DNA spike in plasma and the detection of a monoclonal DNA spike in tumor tissue.

• To estimate the agreement between the fragment length of a spike in tumor tissue and the fragment length of the spike in plasma.

• To estimate the detection rate of elevated FLC in each histology, including diffuse large B-cell/immunoblastic and Burkitt lymphoma.

• To estimate the detection rate of clonal Ig DNA in each histology, including diffuse large B-cell/immunoblastic, Burkitt lymphoma, and Hodgkin lymphoma.

• To analyze clinical and pathologic correlates of detection by the serum/plasma tests:

disease subtype, stage of disease, disease bulk, lactate dehydrogenase, and Ki-67 index.

• To estimate the detection rate of clonotypic B-cells in peripheral blood mononuclear cells from patients with Hodgkin lymphoma.

OUTLINE: This is a multicenter study.

Blood and tissue samples collected at the time of diagnosis are analyzed for serum free light chain and clonal immunoglobulin (Ig) DNA rearrangements and circulating clonotypic B-cells via PCR.

PROJECTED ACCRUAL: A total of 50 patients (25 with diffuse large B-cell/immunoblastic histologies, 15 with Burkitt lymphoma, and 10 with Hodgkin lymphoma) will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of an untreated aggressive B-cell lymphoma, including:

• Diffuse large B cell/immunoblastic lymphoma

• Burkitt lymphoma

• Hodgkin lymphoma

• Serological documentation of HIV infection by any of the FDA-approved tests

• Available diagnostic material from fresh frozen tissue or formalin-fixed paraffin embedded tissue OR willing to undergo a repeat biopsy (fine needle aspiration is acceptable)

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Nonneoplastic Condition

Intervention

Genetic:
• polymerase chain reaction
determination of elevated serum FLC and clonal Ig detection rates in plasma and tumor

Other:
• laboratory biomarker analysis
determination of elevated serum FLC and clonal Ig detection rates in plasma and tumor

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Boston University Cancer Research Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	UNC Hospitals, The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Baylor University Medical Center - Houston	Houston	Texas
United States	Thomas Street Health Center	Houston	Texas
United States	Rebecca and John Moores UCSD Cancer Center	La Jolla	California
United States	UCLA Clinical AIDS Research and Education (CARE) Center	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia	Philadelphia	Pennsylvania
United States	University of California at Davis Center for Aids Research and Education Services	Sacramento	California
United States	Mallinckrodt Institute of Radiology at Washington University Medical Center	Saint Louis	Missouri
United States	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	Benaroya Research Institute at Virginia Mason Medical Center	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
AIDS Malignancy Consortium	National Cancer Institute (NCI), The Emmes Company, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC)		Study entry
Primary	Proportion of patients with Hodgkin lymphoma clonal immunoglobulin (Ig) DNA detection in the plasma		Study entry
Secondary	Agreement between the detection of a monoclonal Ig DNA spike in plasma and the detection of a monoclonal DNA spike in tumor tissue		Study entry
Secondary	Agreement between the fragment length of a spike in tumor tissue and the fragment length of the spike in plasma		Study entry
Secondary	Detection rate of elevated FLC in each histology, including diffuse large B-cell/immunoblastic and Burkitt lymphoma		Study entry
Secondary	Detection rate of clonal Ig DNA in each histology, including diffuse large B-cell/immunoblastic, Burkitt lymphoma, and Hodgkin lymphoma		Study entry
Secondary	Analysis of the clinical and pathologic correlates of detection by the serum/plasma tests: disease subtype, stage of disease, disease bulk, lactate dehydrogenase, and Ki67 index		Study entry
Secondary	Detection rate of clonotypic B cells in peripheral blood mononuclear cells from patients with Hodgkin lymphoma		Study entry