LymphomaNCT00981097
Study of Blood and Tissue Samples From Patients With Aggressive Non-Hodgkin B-Cell Lymphoma or Hodgkin Lymphoma
An observational study of Lymphoma and Nonneoplastic Condition, run by AIDS Malignancy Consortium at 16 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Nonneoplastic Condition
- What is being tested?
- polymerase chain reaction and laboratory biomarker analysis
- How many people
- 52 participants
- Where
- 16 sitesUnited States
- Study dates
- Aug 2009to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons with HIV infection and a diagnosis of an untreated aggressive B-cell lymphoma.
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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
Boston University Cancer Research Center
Boston, Massachusetts, 02118
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Thomas Street Health Center
Houston, Texas, 77009
Baylor University Medical Center - Houston
Houston, Texas, 77030-2707
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, 90024
University of Miami
Miami, Florida, 33136
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia
Philadelphia, Pennsylvania, 19106
University of California at Davis Center for Aids Research and Education Services
Sacramento, California, 95814
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
Benaroya Research Institute at Virginia Mason Medical Center
Seattle, Washington, 98101
Mallinckrodt Institute of Radiology at Washington University Medical Center
St Louis, Missouri, 63110
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467-2490
About this study
Official title: Evaluation of Serum Free Light Chains and Clonal Ig DNA in Plasma From Patients With Aggressive B-Cell Lymphomas
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.
Read the 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.
- Conditions
- Lymphoma, Nonneoplastic Condition
- Being tested
- polymerase chain reaction, laboratory biomarker analysis
- 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
- Medical subject headings
- Lymphoma, HIV Infections, Hodgkin Disease, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polymerase chain reactionGenetic
determination of elevated serum FLC and clonal Ig detection rates in plasma and tumor
laboratory biomarker analysisOther
determination of elevated serum FLC and clonal Ig detection rates in plasma and tumor
| Study group | Role | What they receive |
|---|---|---|
| Specimen Collection | Subjects with a diagnosis of HIV and an untreated aggressive B-cell lymphoma. Receives: Genetic: polymerase chain reaction; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC)
Measured: Study entry
Proportion of patients with Hodgkin lymphoma clonal immunoglobulin (Ig) DNA detection in the plasma
Measured: Study entry
Secondary outcomes (6)
Agreement between the detection of a monoclonal Ig DNA spike in plasma and the detection of a monoclonal DNA spike in tumor tissue
Measured: Study entry
Agreement between the fragment length of a spike in tumor tissue and the fragment length of the spike in plasma
Measured: Study entry
Detection rate of elevated FLC in each histology, including diffuse large B-cell/immunoblastic and Burkitt lymphoma
Measured: Study entry
Detection rate of clonal Ig DNA in each histology, including diffuse large B-cell/immunoblastic, Burkitt lymphoma, and Hodgkin lymphoma
Measured: Study entry
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
Measured: Study entry
Detection rate of clonotypic B cells in peripheral blood mononuclear cells from patients with Hodgkin lymphoma
Measured: Study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), The Emmes Company, LLC
- Responsible party
- Sponsor
- Investigators
- Nina Wagner-Johnston, MD, Principal investigator, Mallinckrodt Institute of Radiology at Washington University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981097
- Sponsor's protocol ID
- AMC-064
- Other IDs
- U01CA121947, CDR0000648183
- Status last verified
- Aug 2020
- First submitted
- 19 Sep 2009
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28508728
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Free Light Chains and Clonal Ig DNA in Plasma From Patients With Aggressive B-Cell Lymphomas
- ClinicalTrials.gov ID
- NCT00981097
- Acronym / sponsor ID
- AMC-064
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- AIDS Malignancy ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI), The Emmes Company, LLC
- Study start
- Aug 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Specimen Collection | – | Genetic: polymerase chain reaction, Other: laboratory biomarker analysisSubjects with a diagnosis of HIV and an untreated aggressive B-cell lymphoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with HIV infection and a diagnosis of an untreated aggressive B-cell lymphoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polymerase chain reactiondetermination of elevated serum FLC and clonal Ig detection rates in plasma and tumor | Genetic | Specimen Collection |
| laboratory biomarker analysisdetermination of elevated serum FLC and clonal Ig detection rates in plasma and tumor | Other | Specimen Collection |
Primary outcome
Proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC)
Time frame: Study entry
Proportion of patients with Hodgkin lymphoma clonal immunoglobulin (Ig) DNA detection in the plasma
Time frame: Study entry
6 secondary outcomes
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
Agreement between the fragment length of a spike in tumor tissue and the fragment length of the spike in plasma
Time frame: Study entry
Detection rate of elevated FLC in each histology, including diffuse large B-cell/immunoblastic and Burkitt lymphoma
Time frame: Study entry
Detection rate of clonal Ig DNA in each histology, including diffuse large B-cell/immunoblastic, Burkitt lymphoma, and Hodgkin lymphoma
Time frame: Study entry
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
Detection rate of clonotypic B cells in peripheral blood mononuclear cells from patients with Hodgkin lymphoma
Time frame: Study entry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Derived from this study: PubMed 28508728Wagner-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Wagner-Johnston, MD principal investigator
Mallinckrodt Institute of Radiology at Washington University Medical Center
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Nonneoplastic Condition, run by AIDS Malignancy Consortium at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC) (time frame: Study entry). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00981097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.