Lymphoma, Non-HodgkinNCT00398372
Clinical and Pathologic Studies in Non-Hodgkin's Lymphoma Patients Receiving Antibody Treatment
A study testing Rituximab and Epratuzumab in people with Lymphoma, Non-Hodgkin and Lymphomas: Non-Hodgkin, run by Stanford University at 1 site in United States.
Trial summary
To characterize the molecular and cell biology of the tumor cells in lymphoma. The mechanism of monoclonal antibody treatment by rituximab or epratuzumab will also be examined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Lymphomas: Non-Hodgkin, Lymphomas: Non-Hodgkin Cutaneous Lymphoma
- What is being tested?
- Rituximab and Epratuzumab
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2000to Sep 2009
- Phase
- Interventional
- 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
Inclusion Criteria:Non-Hodgkin's Lymphoma Patients Receiving Antibody Treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Le20: Clinical and Pathologic Studies in Non-Hodgkin's Lymphoma Patients Receiving Antibody Treatment
To characterize the molecular and cell biology of the tumor cells in lymphoma. The mechanism of monoclonal antibody treatment by rituximab or epratuzumab will also be examined.
- Conditions
- Lymphoma, Non-Hodgkin, Lymphomas: Non-Hodgkin, Lymphomas: Non-Hodgkin Cutaneous Lymphoma, Lymphomas: Non-Hodgkin Diffuse Large B-Cell, Lymphomas: Non-Hodgkin Follicular / Indolent B-Cell, Lymphomas: Non-Hodgkin Mantle Cell
- Being tested
- Rituximab, Epratuzumab
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
EpratuzumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the molecular and cell biology of the tumor cells in lymphoma.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startNov 2000
- Primary completionJun 2007
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, National Institutes of Health (NIH)
- Investigators
- Wen-Kai Weng, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398372
- Sponsor's protocol ID
- LYMNHL0031
- Other IDs
- 200114861, 77550, CA09287, CA111827, LYMNHL0031, NCT00398372
- Status last verified
- Jul 2010
- First submitted
- 9 Nov 2006
- Last updated
- 2 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Le20: Clinical and Pathologic Studies in Non-Hodgkin's Lymphoma Patients Receiving Antibody Treatment
- ClinicalTrials.gov ID
- NCT00398372
- Acronym / sponsor ID
- LYMNHL0031
- Conditions
- Lymphoma, Non-Hodgkin, Lymphomas: Non-Hodgkin, Lymphomas: Non-Hodgkin Cutaneous Lymphoma, Lymphomas: Non-Hodgkin Diffuse Large B-Cell, Lymphomas: Non-Hodgkin Follicular / Indolent B-Cell, Lymphomas: Non-Hodgkin Mantle Cell
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Amgen, National Institutes of Health (NIH)
- Study start
- Nov 2000
- Primary completion
- Jun 2007 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 10 Nov 2006 (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.
To characterize the molecular and cell biology of the tumor cells in lymphoma. The mechanism of monoclonal antibody treatment by rituximab or epratuzumab will also be examined.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Rituximab | Drug | – |
| Epratuzumab | Drug | – |
Primary outcome
To characterize the molecular and cell biology of the tumor cells in lymphoma.
Time frame: 6 months
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 2 Jun 2011.
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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.
Wen-Kai Weng principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rituximab and Epratuzumab in people with Lymphoma, Non-Hodgkin and Lymphomas: Non-Hodgkin, run by Stanford University at 1 site 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 2 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To characterize the molecular and cell biology of the tumor cells in lymphoma. (time frame: 6 months). 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 2 Jun 2011.