Lymphoma, Non-Hodgkin'sPhase 3NCT00363636
A Study of Galiximab + Rituximab Versus Rituximab + Placebo in Follicular Non-Hodgkin's Lymphoma (NHL)
A Phase 3 study testing Galiximab in combination with rituximab in people with Lymphoma, Non-Hodgkin's, run by Biogen.
Trial summary
This is a Phase III, multicenter, global, clinical study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with follicular NHL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin's
- What is being tested?
- Galiximab in combination with rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Apr 2010
- 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
- Aged >= 18 years old at the time of informed consent.
- Histologically confirmed follicular Grade 1-3a NHL.
- Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment.
- Bidimensionally measurable disease with at least 1 lesion >= 2.0 cm in a single dimension.
- Acceptable hematologic, hepatic, and renal function parameters.
- Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs.
Who cannot join
- Follicular lymphoma Grade 3b.
- Rituximab refractory or refractory to anti-CD20 radioimmunotherapy (no response to prior rituximab or prior rituximab-containing regimen, or a response with a TTP of less than 6 months).
- Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to Study Day 1 (6 weeks if nitrosourea or mitomycin C).
- Prior lymphoma vaccine therapy within 12 months prior to Study Day 1.
- Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to Study Day 1.
- Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1.
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- Prior allogeneic transplant.
- Transfusion-dependent subjects.
- Another primary malignancy requiring active treatment (except hormonal therapy).
- Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions, which would compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
- New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 1.
About this study
Official title: A Phase III, Randomized, Double-Blind Study of Galiximab in Combination With Rituximab Compared With Rituximab in Combination With Placebo for the Treatment of Subjects With Relapsed or Refractory, Follicular Non-Hodgkin's Lymphoma
This is a Phase III, multicenter, global, clinical study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with follicular NHL.
The purpose of the study is to compare the clinical benefit of galiximab when given in combination with rituximab as compared with rituximab alone (given with placebo) in subjects with follicular NHL. Safety and pharmacokinetics (PK) of galiximab and rituximab will also be evaluated.
- Conditions
- Lymphoma, Non-Hodgkin's
- Being tested
- Galiximab in combination with rituximab, Rituximab in combination with placebo
- Keywords
- relapsed, NHL, pharmacokinetics, antibody, safety, galiximab, efficacy, rituximab, refractory
- Medical subject headings
- Lymphoma, Non-Hodgkin, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galiximab in combination with rituximabDrug
Galiximab (500mg/m2 IV) in combination with Rituximab (375 mg/m2 IV), weekly x 4
Rituximab in combination with placeboDrug
Rituximab (375 mg/m2 IV) in combination with placebo, weekly x 4
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Galiximab in combination with rituximab |
| 2 | Active comparator | Not described Receives: Drug: Rituximab in combination with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess efficacy as measured by progression free survival (PFS), and determine whether rituximab plus galiximab compared to rituximab plus placebo may extend PFS.
Measured: The duration of this study is approx 4 years
Secondary outcomes (4)
Secondary efficacy measures include: event-free survival, time to progression, duration of response, complete response rate, and overall survival.
Measured: The duration of this study is approx 4 years
Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies.
Measured: The duration of this study is approx 4 years
Pharmacokinetics
Measured: The duration of this study is approx 4 years
Quality of Life using both the Functional Assessment of Cancer Therapy-Lymphoma (FACT-lym) and the EQ-5D (EuroQoL) instruments
Measured: The duration of this study is approx 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionJan 2010
- Study completionApr 2010
Why it stopped: Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-Hodgkin'sStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363636
- Sponsor's protocol ID
- 114-NH-301
- Status last verified
- Mar 2011
- First submitted
- 11 Aug 2006
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind Study of Galiximab in Combination With Rituximab Compared With Rituximab in Combination With Placebo for the Treatment of Subjects With Relapsed or Refractory, Follicular Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00363636
- Acronym / sponsor ID
- 114-NH-301
- Conditions
- Lymphoma, Non-Hodgkin's
- Keywords
- relapsed, NHL, pharmacokinetics, antibody, safety, galiximab, efficacy, rituximab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action.
- Enrolment
- 340 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 15 Aug 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.
This is a Phase III, multicenter, global, clinical study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with follicular NHL.
The purpose of the study is to compare the clinical benefit of galiximab when given in combination with rituximab as compared with rituximab alone (given with placebo) in subjects with follicular NHL. Safety and pharmacokinetics (PK) of galiximab and rituximab will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Galiximab in combination with rituximab |
| 2 | Active comparator | Drug: Rituximab in combination with placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged >= 18 years old at the time of informed consent.
- Histologically confirmed follicular Grade 1-3a NHL.
- Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment.
- Bidimensionally measurable disease with at least 1 lesion >= 2.0 cm in a single dimension.
- Acceptable hematologic, hepatic, and renal function parameters.
Key exclusion criteria (11 listed)
- Follicular lymphoma Grade 3b.
- Rituximab refractory or refractory to anti-CD20 radioimmunotherapy (no response to prior rituximab or prior rituximab-containing regimen, or a response with a TTP of less than 6 months).
- Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to Study Day 1 (6 weeks if nitrosourea or mitomycin C).
- Prior lymphoma vaccine therapy within 12 months prior to Study Day 1.
- Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to Study Day 1.
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 |
|---|---|---|
| Galiximab in combination with rituximabGaliximab (500mg/m2 IV) in combination with Rituximab (375 mg/m2 IV), weekly x 4 | Drug | 1 |
| Rituximab in combination with placeboRituximab (375 mg/m2 IV) in combination with placebo, weekly x 4 | Drug | 2 |
Primary outcome
To assess efficacy as measured by progression free survival (PFS), and determine whether rituximab plus galiximab compared to rituximab plus placebo may extend PFS.
Time frame: The duration of this study is approx 4 years
4 secondary outcomes
Secondary efficacy measures include: event-free survival, time to progression, duration of response, complete response rate, and overall survival.
Time frame: The duration of this study is approx 4 years
Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies.
Time frame: The duration of this study is approx 4 years
Pharmacokinetics
Time frame: The duration of this study is approx 4 years
Quality of Life using both the Functional Assessment of Cancer Therapy-Lymphoma (FACT-lym) and the EQ-5D (EuroQoL) instruments
Time frame: The duration of this study is approx 4 years
Results and safety
The study was stopped early (reason given: Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
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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.
Medical Director study director
Biogen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Galiximab in combination with rituximab in people with Lymphoma, Non-Hodgkin's, run by Biogen.
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 11 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: stopped early, as of the sponsor's last update on 2 Oct 2015. 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 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 was stopped early (reason given: Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action.). 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.
What does the primary outcome measure?
To assess efficacy as measured by progression free survival (PFS), and determine whether rituximab plus galiximab compared to rituximab plus placebo may extend PFS. (time frame: The duration of this study is approx 4 years). 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 Oct 2015.