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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00981097
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : August 7, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The Emmes Company, LLC
Information provided by (Responsible Party):
AIDS Malignancy Consortium

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Lymphoma Nonneoplastic Condition Genetic: polymerase chain reaction Other: laboratory biomarker analysis

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.

Study Design
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Study Type : Observational
Actual Enrollment : 52 participants
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
Study Start Date : August 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC) [ Time Frame: Study entry ]
  2. Proportion of patients with Hodgkin lymphoma clonal immunoglobulin (Ig) DNA detection in the plasma [ Time Frame: Study entry ]

Secondary Outcome Measures :
  1. 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 ]
  2. Agreement between the fragment length of a spike in tumor tissue and the fragment length of the spike in plasma [ Time Frame: Study entry ]
  3. Detection rate of elevated FLC in each histology, including diffuse large B-cell/immunoblastic and Burkitt lymphoma [ Time Frame: Study entry ]
  4. Detection rate of clonal Ig DNA in each histology, including diffuse large B-cell/immunoblastic, Burkitt lymphoma, and Hodgkin lymphoma [ Time Frame: Study entry ]
  5. 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 ]
  6. Detection rate of clonotypic B cells in peripheral blood mononuclear cells from patients with Hodgkin lymphoma [ Time Frame: Study entry ]

Biospecimen Retention:   Samples With DNA
5 tubes of peripheral blood collected along with available tissue blocks or fresh frozen tissue collected at baseline.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981097


Locations
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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
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint 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 Consortium
National Cancer Institute (NCI)
The Emmes Company, LLC
Investigators
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Principal Investigator: Nina Wagner-Johnston, MD Mallinckrodt Institute of Radiology at Washington University Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT00981097    
Other Study ID Numbers: AMC-064
U01CA121947 ( U.S. NIH Grant/Contract )
CDR0000648183 ( Other Identifier: NCI )
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Keywords provided by AIDS Malignancy Consortium:
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
HIV infection
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases