Lymphoma, FollicularPhase 2PREMIERNCT00308087
Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma
A Phase 2 study testing Sargramostim (Leukine) and Rituximab in people with Lymphoma, Follicular, run by Genzyme, a Sanofi Company at 22 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim will be more effective than rituximab alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Follicular
- What is being tested?
- Sargramostim (Leukine) and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 22 sitesin 2 countries
- Study dates
- May 2006to Jun 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Relapsed follicular B-cell lymphoma
- One or more previous therapies for non-Hodgkin's
- At least one measurable tumor by CT scan or MRI
- Additional criteria to be determined at screening visit
Who cannot join
- Rituximab refractory (less than 6 months from last treatment with rituximab to relapse)
- Currently receiving treatment for another cancer
- Infection currently being treated
- Active Hepatitis B
- History of HIV infection
- Pregnant
- Additional criteria to be determined at screening visit
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States21 sites
Study site
Birmingham, Alabama, 35234
Study site
Chicago, Illinois, 60612
Study site
Columbus, Ohio, 43235
Study site
Duluth, Minnesota, 55805-1984
Study site
Elk Grove Village, Illinois, 60007
Study site
Fresh Meadows, New York, 11365
Study site
Gainesville, Florida, 32610-0254
Study site
Hershey, Pennsylvania, 17033-0850
Study site
Houston, Texas, 77030
Study site
Huntsville, Alabama, 35805
Study site
Indianapolis, Indiana, 46202
Study site
Jacksonville, Florida, 32207
Study site
Los Angeles, California, 90095
Study site
Montebello, California, 90640
Study site
New Albany, Indiana, 47150
Study site
New York, New York, 10019
Study site
Ocala, Florida, 34474
Study site
Philadelphia, Pennsylvania, 19104
Study site
Pleasant Hill, California, 94523
Study site
Springfield, Illinois, 62703
Study site
Tampa, Florida, 33612
About this study
Official title: Randomized, Open Label, Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-cell Lymphoma
The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim will be more effective than rituximab alone.
Read the detailed description
On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. As of 29 August 2009, Genzyme assumed responsibility for the close out of the study. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.
The study was terminated early due to low enrollment; significant changes to the protocol would have been required to keep pace with the changing therapeutic landscape of indolent lymphoma.
- Conditions
- Lymphoma, Follicular
- Being tested
- Sargramostim (Leukine), Rituximab
- Keywords
- Sargramostim, Leukine, NHL
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sargramostim (Leukine)Drug
Also called Sargramostim, Leukine, Bay86-5326
Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab
RituximabDrug
Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Active comparator | Not described Receives: Drug: Rituximab |
| Rituximab + Sargramostim | Experimental | Not described Receives: Drug: Sargramostim (Leukine); Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12
Count of number of participants who responded with a Complete Response (complete disappearance of all detectable clinical and radiological evidence of disease) at week 8 and again clinically and radiologically confirmed at week 12.
Measured: Week 8 (confirmed at Week 12)
Secondary outcomes (5)
Summary of Treatment-Emergent Adverse Events (TEAE)
Count of the number of participants who experienced treatment emergent adverse events (TEAEs). TEAEs occurred during the time study intervention was being taken occurring on or after Day 1 and no longer than 30 days after the last dose of study medication.
Measured: up to 12 weeks
Participant Summary of Best Response Across All Visits
Count of participants' best response within categories defined by the International Working Group (IWG):
> Complete Response (complete disappearance of detectable clinical and radiological evidence of disease),
> Complete Response Unconfirmed (unconfirmed complete disappearance),
> Partial Response (>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses),
> Stable Disease (neither response nor disease progression),
> Progression (new lesion or increase by 50% of previously involved sites from nadir).
Measured: up to 24 months
Kaplan-Meier Estimates of Progression-Free Survival
Time to event was measured from the date of randomization to the date of first progressive disease (PD) or death.
Measured: 24 months
Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment
Count of days in which a participant experiences a Partial Response (>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses) or better. Time to event was measured from the date of response to the date of progressive disease (PD) or death.
Measured: 24 months
Summary of Cost Effectiveness
A cost-effectiveness analysis from the payer perspective was to be performed. Only direct medical costs for each patient during the study period were to be included for analysis. Costs were to be calculated by multiplying each health care resource unit by the amount reimbursed by a payer. Health care resource utilization units are a way to normalize the quantity of health care provided to each participant so that costs can be compared.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2006 (estimated)
- Study startMay 2006
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Terminated by sponsor due to low enrollment; see details below
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lymphoma, FollicularStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308087
- Sponsor's protocol ID
- 310421
- Other IDs
- 91499, PREMIER
- Acronym
- PREMIER
- Status last verified
- Dec 2013
- First submitted
- 28 Mar 2006
- Last updated
- 27 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label, Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT00308087
- Acronym / sponsor ID
- PREMIER / 310421
- Conditions
- Lymphoma, Follicular
- Keywords
- Sargramostim, Leukine, NHL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by sponsor due to low enrollment; see details below
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 Mar 2006 (estimated)
- Results
- Posted 30 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim will be more effective than rituximab alone.
Detailed description
On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. As of 29 August 2009, Genzyme assumed responsibility for the close out of the study. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.
The study was terminated early due to low enrollment; significant changes to the protocol would have been required to keep pace with the changing therapeutic landscape of indolent lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Active comparator | Drug: Rituximab |
| Rituximab + Sargramostim | Experimental | Drug: Sargramostim (Leukine), Drug: Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Relapsed follicular B-cell lymphoma
- One or more previous therapies for non-Hodgkin's
- At least one measurable tumor by CT scan or MRI
- Additional criteria to be determined at screening visit
Key exclusion criteria (7 listed)
- Rituximab refractory (less than 6 months from last treatment with rituximab to relapse)
- Currently receiving treatment for another cancer
- Infection currently being treated
- Active Hepatitis B
- History of HIV infection
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 |
|---|---|---|
| Sargramostim (Leukine)Also: Sargramostim, Leukine, Bay86-5326Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab | Drug | Rituximab + Sargramostim |
| RituximabFour doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks | Drug | Rituximab, Rituximab + Sargramostim |
Primary outcome
Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12
Time frame: Week 8 (confirmed at Week 12)
Count of number of participants who responded with a Complete Response (complete disappearance of all detectable clinical and radiological evidence of disease) at week 8 and again clinically and radiologically confirmed at week 12.
5 secondary outcomes
Summary of Treatment-Emergent Adverse Events (TEAE)
Time frame: up to 12 weeks
Participant Summary of Best Response Across All Visits
Time frame: up to 24 months
Kaplan-Meier Estimates of Progression-Free Survival
Time frame: 24 months
Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment
Time frame: 24 months
Summary of Cost Effectiveness
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Monitor study director
Genzyme, a Sanofi Company
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sargramostim (Leukine) and Rituximab in people with Lymphoma, Follicular, run by Genzyme, a Sanofi Company at 22 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 4 inclusion and 7 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 27 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 22 sites in United States, Puerto Rico. 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 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?
Yes. Results are posted in the registry (first posted 30 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12 (time frame: Week 8 (confirmed at Week 12)). 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 27 Dec 2013.