LymphomaNCT01319526
Biomarkers in Blood Samples From Patients With HIV Infection and Stage III or Stage IV Hodgkin Lymphoma Undergoing Chemotherapy
An observational study of Lymphoma and Nonneoplastic Condition, run by AIDS Malignancy Consortium at 2 sites in United States.
Trial summary
RATIONALE: Studying samples of blood in the laboratory from patients undergoing treatment with HIV infection and Hodgkin lymphoma may help doctors learn more about the effects of therapy on HIV. 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?
- DNA analysis, RNA analysis and laboratory biomarker analysis
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Jan 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: Clinical trial participants (subjects who are participating in parent protocol S0816 and provide informed consent for participation in this substudy).
DISEASE CHARACTERISTICS:
- HIV-1 infection, as documented by a rapid HIV test or any FDA-approved HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by western blot at any time prior to study entry
- Documentation may be serologic (positive ELISA and positive western blot), or other federally approved licensed HIV diagnostic test
- Prior documentation of HIV seropositivity is acceptable
- Diagnosis of untreated Hodgkin lymphoma and participation in the parent protocol SWOG-S0816, "A Phase II Trial of Response Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging."
PATIENT CHARACTERISTICS:
- No psychosocial conditions that would prevent study compliance and follow-up, as determined by the principal investigator
- Willing to provide serial blood samples
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
Boston Medical Center
Boston, Massachusetts, 02118
About this study
Official title: Quantification of HIV-1 Reservoirs in HIV-Positive Persons Receiving Response-Adapted Therapy for Stage III-IV Hodgkin Lymphoma: A Companion Protocol to SWOG Protocol S0816 (AMC-073)
RATIONALE: Studying samples of blood in the laboratory from patients undergoing treatment with HIV infection and Hodgkin lymphoma may help doctors learn more about the effects of therapy on HIV.
PURPOSE: This research study is studying biomarkers in blood samples from patients with HIV infection and stage III or stage IV Hodgkin lymphoma undergoing chemotherapy.
Read the detailed description
OBJECTIVES:
Primary
- To quantify HIV-1 persistence in prospectively collected samples from patients on suppressive antiretroviral therapy undergoing chemotherapy for Hodgkin lymphoma.
OUTLINE: This is a multicenter study.
Blood samples are collected before, during, and after treatment for lymphoma for HIV-1 RNA levels using standard and single copy assays and HIV-1 DNA quantification (peripheral blood mononuclear cells).
After completion of treatment, patients are followed up periodically for up to 2 years.
- Conditions
- Lymphoma, Nonneoplastic Condition
- Being tested
- DNA analysis, RNA analysis, laboratory biomarker analysis
- Keywords
- stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, HIV infection
- Medical subject headings
- Lymphoma, Hodgkin Disease, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
RNA analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in viral load from baseline to each subsequent time point
Time frame for outcome measures dependent on study calendar for parent protocol, S0816, which varies by subject's PET scan status.
Measured: Baseline, after each cycle of treatment, restaging, treatment completion, year 1, year 2, study discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Parent protocol (SWOG S0816 / AMC-073) discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1 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
- John W. Mellors, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319526
- Sponsor's protocol ID
- AMC-079
- Other IDs
- CDR0000690149
- Status last verified
- Jul 2020
- First submitted
- 18 Dec 2010
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of HIV-1 Reservoirs in HIV-Positive Persons Receiving Response-Adapted Therapy for Stage III-IV Hodgkin Lymphoma: A Companion Protocol to SWOG Protocol S0816 (AMC-073)
- ClinicalTrials.gov ID
- NCT01319526
- Acronym / sponsor ID
- AMC-079
- Conditions
- Lymphoma, Nonneoplastic Condition
- Keywords
- stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, HIV infection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Parent protocol (SWOG S0816 / AMC-073) discontinued
- Enrolment
- 1 participants (actual)
- Lead sponsor
- AIDS Malignancy ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI), The Emmes Company, LLC
- Study start
- Jun 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 21 Mar 2011 (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 in the laboratory from patients undergoing treatment with HIV infection and Hodgkin lymphoma may help doctors learn more about the effects of therapy on HIV.
PURPOSE: This research study is studying biomarkers in blood samples from patients with HIV infection and stage III or stage IV Hodgkin lymphoma undergoing chemotherapy.
Detailed description
OBJECTIVES:
Primary
- To quantify HIV-1 persistence in prospectively collected samples from patients on suppressive antiretroviral therapy undergoing chemotherapy for Hodgkin lymphoma.
OUTLINE: This is a multicenter study.
Blood samples are collected before, during, and after treatment for lymphoma for HIV-1 RNA levels using standard and single copy assays and HIV-1 DNA quantification (peripheral blood mononuclear cells).
After completion of treatment, patients are followed up periodically for up to 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical trial participants (subjects who are participating in parent protocol S0816 and provide informed consent for participation in this substudy).
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 |
|---|---|---|
| DNA analysis | Genetic | – |
| RNA analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Change in viral load from baseline to each subsequent time point
Time frame: Baseline, after each cycle of treatment, restaging, treatment completion, year 1, year 2, study discontinuation
Time frame for outcome measures dependent on study calendar for parent protocol, S0816, which varies by subject's PET scan status.
Results and safety
The study was stopped early (reason given: Parent protocol (SWOG S0816 / AMC-073) discontinued). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
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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.
John W. Mellors, MD principal investigator
University of Pittsburgh
2 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 2 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: stopped early, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: Parent protocol (SWOG S0816 / AMC-073) discontinued). Results are not available in the source record.
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?
Change in viral load from baseline to each subsequent time point (time frame: Baseline, after each cycle of treatment, restaging, treatment completion, year 1, year 2, study discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2020.