Non-Hodgkin's LymphomaPhase 1/2NCT00048555
Safety and Efficacy of IDEC-114 in Combination With Rituxan in the Treatment of Non-Hodgkin's Lymphoma
A Phase 1/2 study testing IDEC-114 in people with Non-Hodgkin's Lymphoma, run by Biogen at 22 sites in United States.
Trial summary
To determine what side effects and what clinical effect, if any, the administration of this investigational product, IDEC-114 in combination with Rituxan® [Rituxan® as a single agent is approved by the United States Food and Drug Administration (FDA) to treat patients with relapsed or refractory follicular NHL], has… 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?
- IDEC-114
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 22 sitesUnited States
- Study dates
- Nov 2002to Nov 2010
- Phase
- Phase 1/2
- 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
Who may be able to join
- Signed IRB-approved informed consent
- Greater than or equal to 18 years of age
- Proof of follicular lymphoma
- Progressive disease requiring treatment after at least 1 prior standard therapy
- Acceptable hematologic status, liver function, and renal function
- Patients of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment
Who cannot join
- No response to prior Rituxan® or Rituxan®-containing regimen
- Presence of CLL or CNS lymphoma
- Known history of HIV infection or AIDS
- Prior diagnosis of aggressive NHL or mantle-cell lymphoma
- Serious nonmalignant disease
- Pregnant or currently breast feeding
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Research site
Aurora, Colorado, 80010
Research site
Birmingham, Alabama, 35294
Research site
Boston, Massachusetts, 2115
Research site
Buffalo, New York, 14263
Research site
Charlottesville, Virginia, 22908
Research site
Chicago, Illinois, 60611
Research site
Columbia, South Carolina, 29210
Research site
Detroit, Michigan, 48202
Research site
Durham, North Carolina, 27710
Research site
Houston, Texas, 77030
Research site
Los Angeles, California, 90095
Research site
Maywood, Illinois, 60153
Research site
New York, New York, 10021
Research site
Newport Beach, California, 92658
Research site
Omaha, Nebraska, 68198
Research site
Philadelphia, Pennsylvania, 1906
Research site
Rochester, Minnesota, 55905
Research site
Rochester, New York, 14642
Research site
San Diego, California, 92121
Research site
Tampa Bay, Florida, 33612
Research site
Tucson, Arizona, 85724
Research site
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase I/II Trial of IDEC-114 (Anti-CD80 Monoclonal Antibody) in Combination With Rituxan® for Patients With Relapsed or Refractory, Follicular Lymphoma
To determine what side effects and what clinical effect, if any, the administration of this investigational product, IDEC-114 in combination with Rituxan® [Rituxan® as a single agent is approved by the United States Food and Drug Administration (FDA) to treat patients with relapsed or refractory follicular NHL], has in this patient population.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- IDEC-114
- 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.
IDEC-114Drug
Dose Group 1 - 125 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 2 - 250 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 3 - 375 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 4 - 500 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: IDEC-114 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the safety profile and to define the dose of galiximab to be used for the Phase II portion of the study
Measured: March 2010
Secondary outcomes (3)
To evaluate PK
Measured: March 2010
To evaluate efficacy
Measured: March 2010
To monitor for the presence of human anti galiximab antibody and human antichimeric antibody formation
Measured: March 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2002 (estimated)
- Study startNov 2002
- Primary completionMar 2004
- Study completionNov 2010
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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048555
- Sponsor's protocol ID
- 114-21
- Status last verified
- Jan 2011
- First submitted
- 1 Nov 2002
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Leonard JP, Friedberg JW, Younes A, Fisher D, Gordon LI, Moore J, Czuczman M, Miller T, Stiff P, Cheson BD, Forero-Torres A, Chieffo N, McKinney B, Finucane D, Molina A. A phase I/II study of galiximab (an anti-CD80 monoclonal antibody) in combination with rituximab for relapsed or refractory, follicular lymphoma. Ann Oncol. 2007 Jul;18(7):1216-23. doi: 10.1093/annonc/mdm114. Epub 2007 Apr 29.
PubMed 17470451
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of IDEC-114 (Anti-CD80 Monoclonal Antibody) in Combination With Rituxan® for Patients With Relapsed or Refractory, Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT00048555
- Acronym / sponsor ID
- 114-21
- Conditions
- Non-Hodgkin's Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Mar 2004 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 5 Nov 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.
To determine what side effects and what clinical effect, if any, the administration of this investigational product, IDEC-114 in combination with Rituxan® [Rituxan® as a single agent is approved by the United States Food and Drug Administration (FDA) to treat patients with relapsed or refractory follicular NHL], has in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: IDEC-114 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed IRB-approved informed consent
- Greater than or equal to 18 years of age
- Proof of follicular lymphoma
- Progressive disease requiring treatment after at least 1 prior standard therapy
- Acceptable hematologic status, liver function, and renal function
Key exclusion criteria (6 listed)
- No response to prior Rituxan® or Rituxan®-containing regimen
- Presence of CLL or CNS lymphoma
- Known history of HIV infection or AIDS
- Prior diagnosis of aggressive NHL or mantle-cell lymphoma
- Serious nonmalignant disease
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 |
|---|---|---|
| IDEC-114Dose Group 1 - 125 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 2 - 250 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 3 - 375 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 4 - 500 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions | Drug | 1 |
Primary outcome
To characterize the safety profile and to define the dose of galiximab to be used for the Phase II portion of the study
Time frame: March 2010
3 secondary outcomes
To evaluate PK
Time frame: March 2010
To evaluate efficacy
Time frame: March 2010
To monitor for the presence of human anti galiximab antibody and human antichimeric antibody formation
Time frame: March 2010
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 16 Sep 2013.
- Background: PubMed 17470451Leonard JP, Friedberg JW, Younes A, Fisher D, Gordon LI, Moore J, Czuczman M, Miller T, Stiff P, Cheson BD, Forero-Torres A, Chieffo N, McKinney B, Finucane D, Molina A. A phase I/II study of galiximab (an anti-CD80 monoclonal antibody) in combination with rituximab for relapsed or refractory, follicular lymphoma. Ann Oncol. 2007 Jul;18(7):1216-23. doi: 10.1093/annonc/mdm114. Epub 2007 Apr 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IDEC-114 in people with Non-Hodgkin's Lymphoma, run by Biogen at 22 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?
The sponsor lists 6 inclusion and 6 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 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
To characterize the safety profile and to define the dose of galiximab to be used for the Phase II portion of the study (time frame: March 2010). 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 NCT00048555, 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 16 Sep 2013.