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


N/A
18 Years
N/A
Not Enrolling
Both
Lymphoma, Nonneoplastic Condition

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC)

Outcome Time Frame:

Study entry

Safety Issue:

No

Principal Investigator

Nina Wagner-Johnston, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mallinckrodt Institute of Radiology at Washington University Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000648183

NCT ID:

NCT00981097

Start Date:

August 2009

Completion Date:

June 2013

Related Keywords:

  • Lymphoma
  • Nonneoplastic Condition
  • 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
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
Montefiore Medical CenterBronx, New York  10467-2490
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
UCLA Clinical AIDS Research and Education (CARE) CenterLos Angeles, California  90024
Boston University Cancer Research CenterBoston, Massachusetts  02118
Mallinckrodt Institute of Radiology at Washington University Medical CenterSt. Louis, Missouri  63110
University of MiamiMiami, Florida  33136
Pennsylvania Oncology Hematology Associates, Incorporated - PhiladelphiaPhiladelphia, Pennsylvania  19106
Benaroya Research Institute at Virginia Mason Medical CenterSeattle, Washington  98101
University of California at Davis Center for Aids Research and Education ServicesSacramento, California  95814
Thomas Street Health CenterHouston, Texas  77009
UNC Hospitals, The University of North Carolina at Chapel HillChapel Hill, North Carolina  27599