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

This study has been completed.
Sponsor:
Collaborators:
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00981097
First received: September 19, 2009
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Lymphoma
Nonneoplastic Condition
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Serum Free Light Chains and Clonal Ig DNA in Plasma From Patients With Aggressive B-Cell Lymphomas

Resource links provided by NLM:


Further study details as provided by AIDS Malignancy Clinical Trials Consortium:

Primary Outcome Measures:
  • Proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC) [ Time Frame: Study entry ] [ Designated as safety issue: No ]
  • Proportion of patients with Hodgkin lymphoma clonal immunoglobulin (Ig) DNA detection in the plasma [ Time Frame: Study entry ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Agreement between the detection of a monoclonal Ig DNA spike in plasma and the detection of a monoclonal DNA spike in tumor tissue [ Time Frame: Study entry ] [ Designated as safety issue: No ]
  • Agreement between the fragment length of a spike in tumor tissue and the fragment length of the spike in plasma [ Time Frame: Study entry ] [ Designated as safety issue: No ]
  • Detection rate of elevated FLC in each histology, including diffuse large B-cell/immunoblastic and Burkitt lymphoma [ Time Frame: Study entry ] [ Designated as safety issue: No ]
  • Detection rate of clonal Ig DNA in each histology, including diffuse large B-cell/immunoblastic, Burkitt lymphoma, and Hodgkin lymphoma [ Time Frame: Study entry ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Study entry ] [ Designated as safety issue: No ]
  • Detection rate of clonotypic B cells in peripheral blood mononuclear cells from patients with Hodgkin lymphoma [ Time Frame: Study entry ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

5 tubes of peripheral blood collected along with available tissue blocks or fresh frozen tissue collected at baseline.


Enrollment: 52
Study Start Date: August 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Specimen Collection
Subjects with a diagnosis of HIV and an untreated aggressive B-cell lymphoma.
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Persons with HIV infection and a diagnosis of an untreated aggressive B-cell lymphoma.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981097

Locations
United States, California
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States, 90024
University of California at Davis Center for Aids Research and Education Services
Sacramento, California, United States, 95814
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
United States, Missouri
Mallinckrodt Institute of Radiology at Washington University Medical Center
St. Louis, Missouri, United States, 63110
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St. Louis, Missouri, United States, 63110
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467-2490
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia
Philadelphia, Pennsylvania, United States, 19106
United States, Texas
Thomas Street Health Center
Houston, Texas, United States, 77009
Baylor University Medical Center - Houston
Houston, Texas, United States, 77030-2707
United States, Washington
Benaroya Research Institute at Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
AIDS Malignancy Clinical Trials Consortium
The EMMES Corporation
Investigators
Principal Investigator: Nina Wagner-Johnston, MD Mallinckrodt Institute of Radiology at Washington University Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier: NCT00981097     History of Changes
Other Study ID Numbers: AMC-064, U01CA121947, CDR0000648183
Study First Received: September 19, 2009
Last Updated: August 27, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by AIDS Malignancy Clinical Trials Consortium:
HIV infection
HIV-associated Hodgkin lymphoma
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
contiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult Burkitt lymphoma
stage I adult Burkitt lymphoma
stage III adult Burkitt lymphoma
stage IV adult Burkitt lymphoma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
stage I adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
stage I adult immunoblastic large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage IV adult immunoblastic large cell lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, B-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 30, 2014