Low-Grade or Follicular B-Cell Non-Hodgkin's LymphomaPhase 3NCT00168740
Treatment of Relapsed Low-Grade or Follicular Lymphoma With Rituximab (Also Known as Rituxan, IDEC-C2B8, IDEC-102)
A Phase 3 study testing rituximab in people with Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma, run by Biogen at 31 sites in 2 countries.
Trial summary
Rituximab is an antibody made in a laboratory. It binds to lymphoma cells and kills them. Treatment of recurrent B-cell lymphoma with rituximab may delay or prevent relapses. A total of 166 patients with recurrent B-cell lymphoma were given intravenous rituximab once a week for 4 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma
- What is being tested?
- rituximab
- How many people
- 150 participants
- Where
- 31 sitesin 2 countries
- Study dates
- Apr 1995to 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
Who may be able to join
- Diagnosis of relapsed, low-grade or follicular B-cell lymphoma
- CD20-positive lymphoma
- Progressive, measurable disease
- Sign informed consent
- 3 weeks beyond standard therapy
- Good performance status
- Adequate hematologic, renal, and hepatic function
Who cannot join
- Chronic lymphocytic leukemia
- Lesions greater than or equal to 10 cm in diameter
- CNS lymphoma
- AIDS-related lymphoma
- Pleural effusions or ascites secondary to lymphoma
- Active, opportunistic infection
Show all 9Show fewer
- Serious nonmalignant disease
- Prior investigational therapies, including prior anti-CD20 therapy
- Recent major surgery
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States29 sites
University of Maryland Cancer Center
Baltimore, Maryland
Roswell Park Cancer Center
Buffalo, New York
University of Virginia
Charlottesville, Virginia
Robert H. Lurie Cancer Center, Northwestern University
Chicago, Illinois
Texas Oncology, P.A.
Dallas, Texas
Rocky Mountain Cancer Center
Denver, Colorado
City of Hope Natioal Medical Center
Duarte, California
Michigan State University
East Lansing, Michigan
M.D. Anderson Cancer Center
Houston, Texas
University of Iowa General Hospital
Iowa City, Iowa
Scripps Memorial Hospital
La Jolla, California
UCSD Stem Cell Laboratory
La Jolla, California
University of Kentucky Medical Center
Lexington, Kentucky
University of Arkansas for Medical Sciences
Little Rock, Arkansas
The West Clinic, P.C.
Memphis, Tennessee
Hoag Hospital
Newport Beach, California
Fox Chase Cancer Center
Philadelphia, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania
University of Rochester Cancer Center
Rochester, New York
Sutter Cancer Center
Sacramento, California
University of Texas Health Sciences Center
San Antonio, Texas
Sidney Kimmel Cancer Center
San Diego, California
University of California, San Francisco
San Francisco, California
Fred Hutchinson Cancer Research Center
Seattle, Washington
Louisiana State University
Shreveport, Louisiana
St. Louis University Medical Center
St Louis, Missouri
Stanford University Medical Center
Stanford, California
Kaiser Permanente Medical Center
Vallejo, California
Georgetown University Medical Center
Washington D.C., District of Columbia
Canada2 sites
Ottawa General Hospital
Ottawa, Ontario
Toronto-Sunnybrook Regional Cancer Center
Toronto, Ontario
About this study
Official title: Pivotal Phase III Multi-Center Study to Evaluate the Safety and Efficacy of Once Weekly Times Four Dosing of IDEC-C2B8 (IDEC-102) in Patients With Relapsed Low-Grade or Follicular B-Cell Lymphoma
Rituximab is an antibody made in a laboratory. It binds to lymphoma cells and kills them. Treatment of recurrent B-cell lymphoma with rituximab may delay or prevent relapses. A total of 166 patients with recurrent B-cell lymphoma were given intravenous rituximab once a week for 4 weeks. The patients' tumors were measured before and after treatment. Ten patients had a complete response and 70 patients had a partial response to rituximab. The median duration of response was 11.2 months.
- Being tested
- rituximab
- Keywords
- rituximab, Rituxan, B-cell lymphoma, low-grade, follicular, anti-CD20 monoclonal antibody
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Secondary outcomes (2)
time to disease progression
progressive disease-free interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 1995
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 Low-Grade or Follicular B-Cell Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by BiogenThe 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Antonio J. Grillo-Lopez, M.D., Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168740
- Sponsor's protocol ID
- IDEC-102-05
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Publications
McLaughlin P, Grillo-Lopez AJ, Link BK, Levy R, Czuczman MS, Williams ME, Heyman MR, Bence-Bruckler I, White CA, Cabanillas F, Jain V, Ho AD, Lister J, Wey K, Shen D, Dallaire BK. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998 Aug;16(8):2825-33. doi: 10.1200/JCO.1998.16.8.2825.
PubMed 9704735
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Phase III Multi-Center Study to Evaluate the Safety and Efficacy of Once Weekly Times Four Dosing of IDEC-C2B8 (IDEC-102) in Patients With Relapsed Low-Grade or Follicular B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00168740
- Acronym / sponsor ID
- IDEC-102-05
- Keywords
- rituximab, Rituxan, B-cell lymphoma, low-grade, follicular, anti-CD20 monoclonal antibody
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Apr 1995
- First posted
- 15 Sep 2005 (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.
Rituximab is an antibody made in a laboratory. It binds to lymphoma cells and kills them. Treatment of recurrent B-cell lymphoma with rituximab may delay or prevent relapses. A total of 166 patients with recurrent B-cell lymphoma were given intravenous rituximab once a week for 4 weeks. The patients' tumors were measured before and after treatment. Ten patients had a complete response and 70 patients had a partial response to rituximab. The median duration of response was 11.2 months.
Study design
- Primary purpose
- Treatment
- 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
Key inclusion criteria (7 listed)
- Diagnosis of relapsed, low-grade or follicular B-cell lymphoma
- CD20-positive lymphoma
- Progressive, measurable disease
- Sign informed consent
- 3 weeks beyond standard therapy
Key exclusion criteria (9 listed)
- Chronic lymphocytic leukemia
- Lesions greater than or equal to 10 cm in diameter
- CNS lymphoma
- AIDS-related lymphoma
- Pleural effusions or ascites secondary to 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 |
|---|---|---|
| rituximab | Drug | – |
Primary outcome
overall response rate
2 secondary outcomes
time to disease progression
progressive disease-free interval
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 15 Sep 2005.
- Results publication: PubMed 9704735McLaughlin P, Grillo-Lopez AJ, Link BK, Levy R, Czuczman MS, Williams ME, Heyman MR, Bence-Bruckler I, White CA, Cabanillas F, Jain V, Ho AD, Lister J, Wey K, Shen D, Dallaire BK. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998 Aug;16(8):2825-33. doi: 10.1200/JCO.1998.16.8.2825.
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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.
Antonio J. Grillo-Lopez, M.D. study director
Biogen
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rituximab in people with Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma, run by Biogen at 31 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. 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 15 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Canada. 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?
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?
overall response rate. 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 NCT00168740, 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 15 Sep 2005.