Non-Hodgkin's LymphomaPhase 2NCT00044902
Monoclonal Antibody Treatment for Non-Hodgkin's Lymphoma (Low-Grade)
A Phase 2 study testing epratuzumab in people with Non-Hodgkin's Lymphoma, run by Amgen.
Trial summary
Epratuzumab is currently being studied in combination with rituximab, for the treatment of patients with low-grade NHL who failed previous chemotherapy and have never received rituximab or who received rituximab as a single agent or in combination with chemotherapy as their last treatment and who demonstrated a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- epratuzumab
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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
- Diagnosis of relapsed or refractory low-grade, CD20+, B-cell NHL * Received and failed at least 1 prior regimen of chemotherapy * Rituximab-naive or received prior rituximab in their last treatment (single agent or in combination with chemotherapy) and demonstrated a time to progression of at least 12 months.
About this study
Epratuzumab is currently being studied in combination with rituximab, for the treatment of patients with low-grade NHL who failed previous chemotherapy and have never received rituximab or who received rituximab as a single agent or in combination with chemotherapy as their last treatment and who demonstrated a partial response or complete response for at least 12 months.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- 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.
epratuzumabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044902
- Sponsor's protocol ID
- 20010138
- Status last verified
- Dec 2007
- First submitted
- 6 Sep 2002
- Last updated
- 28 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monoclonal Antibody Treatment for Non-Hodgkin's Lymphoma (Low-Grade)
- ClinicalTrials.gov ID
- NCT00044902
- Acronym / sponsor ID
- 20010138
- Conditions
- Non-Hodgkin's Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- First posted
- 9 Sep 2002 (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.
Epratuzumab is currently being studied in combination with rituximab, for the treatment of patients with low-grade NHL who failed previous chemotherapy and have never received rituximab or who received rituximab as a single agent or in combination with chemotherapy as their last treatment and who demonstrated a partial response or complete response for at least 12 months.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| epratuzumab | Drug | – |
Primary outcome
Not reported in the source record.
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 28 Dec 2007.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing epratuzumab in people with Non-Hodgkin's Lymphoma, run by Amgen.
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 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 28 Dec 2007.