LymphomaPhase 3NCT00022685
Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma
A Phase 3 study testing epratuzumab in people with Lymphoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies such as epratuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase III trial to determine the effectiveness of epratuzumab in treating patients who have low-grade non-Hodgkin's lymphoma that has not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- epratuzumab
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to not given
- Phase
- Phase 3
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed low-grade follicular B-cell non-Hodgkin's lymphoma
- Small cleaved cell OR
- Mixed cell
- The following are ineligible:
- Primary CNS lymphoma
- HIV lymphoma
- Richter's lymphoma
- Bulky disease (any single mass greater than 10 cm)
- Pleural effusion with positive cytology for lymphoma
- Failed prior standard chemotherapy for non-Hodgkin's lymphoma
- Refractory to at least 1 prior treatment with rituximab
- Disease progression or failure to achieve objective response within 6 months of beginning rituximab therapy
- At least 1 bidimensionally measurable lesion
- At least 1.5 cm by CT scan NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
- ECOG 0-2
Life expectancy:
- At least 4 months
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 50,000/mm^3
- Hemoglobin at least 8 g/dL
- Transfusion independent
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)*
- Alkaline phosphatase less than 2 times ULN*
- AST less than 2 times ULN* NOTE: *Unless lymphoma-related
Renal:
- Creatinine no greater than 1.5 times ULN unless lymphoma-related
Other:
- No other malignancy within the past 5 years except squamous or basal cell skin cancer or carcinoma in situ of the cervix
- No other serious condition or infection that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- At least 12 weeks since prior autologous stem cell transplantation
- No prior radioimmunoconjugate therapies
Chemotherapy:
- See Disease Characteristics
- No more than 4 prior treatment regimens
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- At least 2 weeks since prior corticosteroids
- No concurrent steroids
Radiotherapy:
- See Biologic therapy
- At least 4 weeks since prior radiotherapy to target lesion
Surgery:
- At least 4 weeks since prior major surgery unless recovered
Other:
- At least 4 weeks since prior experimental therapies
- No other concurrent investigational or therapeutic agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
About this study
Official title: A Phase III Clinical Trial of Immunotherapy With Humanized LL2 IgG (Epratuzumab) in Patients With Low-Grade Follicular, B-Cell Non-Hodgkin's Lymphoma Refractory to Rituxan (Rituximab)
RATIONALE: Monoclonal antibodies such as epratuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase III trial to determine the effectiveness of epratuzumab in treating patients who have low-grade non-Hodgkin's lymphoma that has not responded to chemotherapy or rituximab.
Read the detailed description
OBJECTIVES:
- Determine the safety of epratuzumab in patients with rituximab-refractory low-grade follicular B-cell non-Hodgkin's lymphoma.
- Confirm the convenient administration of this drug in this patient population.
- Determine the efficacy of this drug in terms of objective response rate in these patients.
- Determine the duration of response and time to progression in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive epratuzumab IV over 15-60 minutes on days 1, 8, 15, and 22.
Patients are followed every 8 weeks for 10 months and then every 3 months for up to 4 years.
PROJECTED ACCRUAL: Approximately 30-100 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- epratuzumab
- Keywords
- recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epratuzumabBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 2001
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.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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 3
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Peter J. Rosen, MD, Study chair, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022685
- Sponsor's protocol ID
- CDR0000068842
- Other IDs
- UCLA-0009041, IM-T-hLL2-07, UCLA-BB-IND-7124, NCI-G01-2004
- Status last verified
- Apr 2003
- First submitted
- 10 Aug 2001
- Last updated
- 19 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Trial of Immunotherapy With Humanized LL2 IgG (Epratuzumab) in Patients With Low-Grade Follicular, B-Cell Non-Hodgkin's Lymphoma Refractory to Rituxan (Rituximab)
- ClinicalTrials.gov ID
- NCT00022685
- Acronym / sponsor ID
- CDR0000068842
- Conditions
- Lymphoma
- Keywords
- recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2001
- First posted
- 27 Jan 2003 (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: Monoclonal antibodies such as epratuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase III trial to determine the effectiveness of epratuzumab in treating patients who have low-grade non-Hodgkin's lymphoma that has not responded to chemotherapy or rituximab.
Detailed description
OBJECTIVES:
- Determine the safety of epratuzumab in patients with rituximab-refractory low-grade follicular B-cell non-Hodgkin's lymphoma.
- Confirm the convenient administration of this drug in this patient population.
- Determine the efficacy of this drug in terms of objective response rate in these patients.
- Determine the duration of response and time to progression in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive epratuzumab IV over 15-60 minutes on days 1, 8, 15, and 22.
Patients are followed every 8 weeks for 10 months and then every 3 months for up to 4 years.
PROJECTED ACCRUAL: Approximately 30-100 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- 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 |
|---|---|---|
| epratuzumab | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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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.
Peter J. Rosen, MD study chair
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing epratuzumab in people with Lymphoma, run by Jonsson Comprehensive Cancer Center 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: status not confirmed, as of the sponsor's last update on 19 Dec 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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.
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 19 Dec 2013.