Clinical trial NCT00981097: Study of Blood and Tissue Samples From Patients With Aggressive Non-Hodgkin B-Cell Lymphoma or Hodgkin Lymphoma
Official title: Evaluation of Serum Free Light Chains and Clonal Ig DNA in Plasma From Patients With Aggressive B-Cell Lymphomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Nonneoplastic Condition
Keywords: 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
Lead sponsor: AIDS Malignancy Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: The Emmes Company, LLC
First posted: 2009-09-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons with HIV infection and a diagnosis of an untreated aggressive B-cell lymphoma.

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.

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 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

Primary outcomes:
measure: Proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC)
timeFrame: Study entry
measure: Proportion of patients with Hodgkin lymphoma clonal immunoglobulin (Ig) DNA detection in the plasma
timeFrame: Study entry
Secondary outcomes:
measure: Agreement between the detection of a monoclonal Ig DNA spike in plasma and the detection of a monoclonal DNA spike in tumor tissue
timeFrame: Study entry
measure: Agreement between the fragment length of a spike in tumor tissue and the fragment length of the spike in plasma
timeFrame: Study entry
measure: Detection rate of elevated FLC in each histology, including diffuse large B-cell/immunoblastic and Burkitt lymphoma
timeFrame: Study entry
measure: Detection rate of clonal Ig DNA in each histology, including diffuse large B-cell/immunoblastic, Burkitt lymphoma, and Hodgkin lymphoma
timeFrame: Study entry
measure: 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
timeFrame: Study entry
measure: Detection rate of clonotypic B cells in peripheral blood mononuclear cells from patients with Hodgkin lymphoma
timeFrame: Study entry
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Rebecca and John Moores UCSD Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA Clinical AIDS Research and Education (CARE) Center
state: California
city: Sacramento
country: United States
facility: University of California at Davis Center for Aids Research and Education Services
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Boston University Cancer Research Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Mallinckrodt Institute of Radiology at Washington University Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Hospitals, The University of North Carolina at Chapel Hill
state: North Carolina
city: Philadelphia
country: United States
facility: Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Thomas Street Health Center
state: Texas
city: Houston
country: United States
facility: Baylor University Medical Center - Houston
state: Texas
city: Seattle
country: United States
facility: Benaroya Research Institute at Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Mallinckrodt Institute of Radiology at Washington University Medical Center
name: Nina Wagner-Johnston, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wagner-Johnston ND, Lensing S, Noy A, Ratner L, Henry D, Lee JY, Silver S, Faham M, Ambinder RF. High frequency of identical clonal immunoglobulin DNA in pre-treatment tumor and plasma from untreated patients with HIV-associated lymphoma: prospective multicenter trial of the AIDS malignancies consortium (AMC 064). Leuk Lymphoma. 2017 Dec;58(12):2939-2942. doi: 10.1080/10428194.2017.1317095. Epub 2017 May 16.