Lymphoma, Non-HodgkinPhase 3NCT02417129
BI 695500 vs Rituxan First Line Treatment in Patients With Low Tumor Burden Follicular Lymphoma
A Phase 3 study testing Rituximab and BI 695500 in people with Lymphoma, Non-Hodgkin, run by Boehringer Ingelheim at 21 sites in 6 countries.
Trial summary
This is a Phase III, multicenter, randomized, double-blind, parallel-arm, active comparator trial to evaluate BI 695500 versus rituximab as a first-line immunotherapy treatment in patients with LTBFL. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- Rituximab and BI 695500
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 21 sitesin 6 countries
- Study dates
- Apr 2015to Dec 2015
- Phase
- Phase 3
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent that is consistent with ICH GCP guidelines and local legislations.
- Male or female patients, at least 18 years of age at Screening.
- Histologically-confirmed, stage II - IV NHL (CD20+ FL of Grades 1, 2, or 3a).
- Low tumor burden according to the GELF criteria
- Diagnostic biopsies will be centrally reviewed by expert pathologists to confirm correct histology in accordance with WHO guidelines. If the interval since diagnosis is > 12 months, a new biopsy will be required to confirm the histology remained unchanged.
- Patients not previously treated for their FL, including any previous treatment for FL under clinical trials.
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- ECOG performance status of 0 to 1.
- Have at least one measurable lesion as per the International Working Group (IWG) criteria 2007 at Screening (lesion clearly measurable in at least two perpendicular dimensions
- Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow) within 28 days prior to randomization
- Adequate renal and liver function:
- For participants of reproductive potential (males and females), use of a medically acceptable method of contraception during the trial
Who cannot join
- Transformation to high-grade lymphoma (secondary to low-grade lymphoma) prior to study entry.
- Circulating tumor cells = 5 × 109/L.
- Presence or history of central nervous system lymphoma.
- Patients receiving current treatment with corticosteroids must not be receiving a dose exceeding 20 mg/day prednisone or equivalent.
- Patients with prior or concomitant malignancies within 5 years prior to Screening
- Major surgery within 28 days prior to randomization.
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- Active, chronic or persistent infection that might worsen with immunosuppressive treatment; positive for HIV or tuberculosis (TB) at Screening. Patients who are confirmed positive and those who have active infections are excluded from the trial participation.
- Patients with serological evidence of HBV infection. Patients seropositive because of HBV vaccine are eligible. HBV positive patients may participate following consultation with a hepatitis expert regarding monitoring and use of HBV antiviral therapy, and provided they agree to receive treatment as indicated.
- Serious underlying medical conditions, that, per the Investigator¿s discretion, could impair the ability of the patient to participate in the trial.
- Known hypersensitivity or allergy to murine products.
- History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of the trial medication.
- Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit.
- Prior treatment with BI 695500 and/or rituximab.
- Patients who received any prior therapy using mAbs will be excluded; this does not apply to other biological drugs such as growth factors or anticoagulants.
- Treatment within a clinical trial within 4 weeks prior to initiation of trial treatment. Patients who have received treatment with a drug that has not received regulatory approval for any indication within 4 weeks or a minimum of 5 half-lives, whichever is longer, of the initial dose of trial medication.
- Any other co-existing medical or psychological condition(s) that will preclude participation in the trial or compromise ability to give informed consent and/or comply with study procedures.
- Pregnancy or breast feeding. For women of childbearing potential, a positive serum pregnancy test at the Screening Visit.
- Patients who have significant cardiac disease, including but not limited to congestive heart failure of Class III or IV of the NYHA classification; uncontrolled angina or arrhythmia; any uncontrolled or severe cardiovascular or cerebrovascular disease; or uncontrolled hypertension.
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
United States13 sites
Boehringer Ingelheim Investigational Site
Albany, Georgia
Boehringer Ingelheim Investigational Site
Bakersfield, California
Boehringer Ingelheim Investigational Site
Burbank, California
Boehringer Ingelheim Investigational Site
Corpus Christi, Texas
Boehringer Ingelheim Investigational Site
East Setauket, New York
Boehringer Ingelheim Investigational Site
Fayetteville, North Carolina
Boehringer Ingelheim Investigational Site
Loma Linda, California
Boehringer Ingelheim Investigational Site
Middletown, Ohio
Boehringer Ingelheim Investigational Site
Morristown, New Jersey
Boehringer Ingelheim Investigational Site
Muscle Shoals, Alabama
Boehringer Ingelheim Investigational Site
Northbrook, Illinois
Boehringer Ingelheim Investigational Site
Ogden, Utah
Boehringer Ingelheim Investigational Site
Pittsfield, Massachusetts
Belgium2 sites
Boehringer Ingelheim Investigational Site
Leuven
Boehringer Ingelheim Investigational Site
Namur
Bulgaria2 sites
Boehringer Ingelheim Investigational Site
Plovdiv
Boehringer Ingelheim Investigational Site
Sofia
Czechia2 sites
Boehringer Ingelheim Investigational Site
Brno
Boehringer Ingelheim Investigational Site
Prague
About this study
Official title: A Phase III, Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate Efficacy and Safety of BI 695500 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma
This is a Phase III, multicenter, randomized, double-blind, parallel-arm, active comparator trial to evaluate BI 695500 versus rituximab as a first-line immunotherapy treatment in patients with LTBFL. Patients will be randomly assigned in a 1:1 ratio to receive 375 mg/m2 of BI 695500 or rituximab via intravenous (IV) infusion once a week for 4 weeks (total of 4 dosages administered on Days 1, 8, 15, and 22). Disease assessments will be performed at the End of Study (EOS) Visit at Week 30.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- Rituximab, BI 695500
- 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.
RituximabDrug
BI 695500 375 mg/M2
BI 695500Drug
BI 695500 375 mg/M2
| Study group | Role | What they receive |
|---|---|---|
| BI 695500 | Experimental | 375 mg/m2; One intravenous infusion once a week for 4 weeks Receives: Drug: BI 695500 |
| Rituximab (US reference product) | Active comparator | 375 mg/m2; One intravenous infusion once a week for 4 weeks Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Measured as Overall Response Rate (ORR) at Week 30 for BI 695500 Versus Rituximab
The primary objective of this trial was to evaluate statistical equivalence of efficacy as assessed by Overall Response (measured as Overall Response Rate (ORR)) at Week 30 for treatment with BI 695500 versus rituximab (Rituxan®) in patients with untreated low tumor burden follicular lymphoma (LTBFL).
The overall response measured as Overall Response Rate (ORR), which is the completed response (CR) and the partial response (PR) at Week 30, approximately 26 weeks after the completion of study treatment, as defined by International Working Group (IWG) criteria 2007 via an independent radiology assessment.
Two patient were randomized and treated with BI 695500, whereas no patient was treated with rituximab in this trial.
Measured: From first administration of study medication until 30 weeks thereafter.
Secondary outcomes (2)
Extrapolated Area Under the Concentration-time Curve of BI 695500 or Rituximab at Steady State Over the Interval 0 Hour (h) to the Next Dose of Trial Medication (AUC0-τ, ss)
Extrapolated area under the concentration-time curve of BI 695500 or rituximab in plasma at steady state over the interval 0 hour (h) to the next dose of trial medication (AUC0-τ, ss) established by population pharmacokinetics.
Measured: Sample timepoints Day 1, 8, 22, 23-24 (24-48 hours from start of Cycle 4 infusion), 24-26 (48-96 hours from start of Cycle 4 infusion), 26-36 (96-336 hours from start of Cycle 4 infusion), 78, 134, 204
Immunogenicity at Week 30
Immunogenicity (rate of anti-drug antibodies) at Week 30 presented as the number of participants having Immunogenicity at Week 30.
This endpoint was not summarized for arm ' rituximab ', as two patient were randomized and treated with BI 695500, thus no patient was treated with rituximab in this trial.
Measured: Day 204 or end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionDec 2015
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, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Double blind
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417129
- Sponsor's protocol ID
- 1301.6
- Other IDs
- 2014-004544-36, 2014
- Status last verified
- Dec 2016
- First submitted
- 10 Apr 2015
- Last updated
- 30 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate Efficacy and Safety of BI 695500 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT02417129
- Acronym / sponsor ID
- 1301.6
- Conditions
- Lymphoma, Non-Hodgkin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Posted 30 Jan 2017
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, randomized, double-blind, parallel-arm, active comparator trial to evaluate BI 695500 versus rituximab as a first-line immunotherapy treatment in patients with LTBFL. Patients will be randomly assigned in a 1:1 ratio to receive 375 mg/m2 of BI 695500 or rituximab via intravenous (IV) infusion once a week for 4 weeks (total of 4 dosages administered on Days 1, 8, 15, and 22). Disease assessments will be performed at the End of Study (EOS) Visit at Week 30.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 695500 | Experimental | Drug: BI 695500375 mg/m2; One intravenous infusion once a week for 4 weeks |
| Rituximab (US reference product) | Active comparator | Drug: Rituximab375 mg/m2; One intravenous infusion once a week for 4 weeks |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent that is consistent with ICH GCP guidelines and local legislations.
- Male or female patients, at least 18 years of age at Screening.
- Histologically-confirmed, stage II - IV NHL (CD20+ FL of Grades 1, 2, or 3a).
- Low tumor burden according to the GELF criteria
- Diagnostic biopsies will be centrally reviewed by expert pathologists to confirm correct histology in accordance with WHO guidelines. If the interval since diagnosis is > 12 months, a new biopsy will be required to confirm the histology remained unchanged.
Key exclusion criteria (18 listed)
- Transformation to high-grade lymphoma (secondary to low-grade lymphoma) prior to study entry.
- Circulating tumor cells = 5 × 109/L.
- Presence or history of central nervous system lymphoma.
- Patients receiving current treatment with corticosteroids must not be receiving a dose exceeding 20 mg/day prednisone or equivalent.
- Patients with prior or concomitant malignancies within 5 years prior to Screening
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 |
|---|---|---|
| RituximabBI 695500 375 mg/M2 | Drug | Rituximab (US reference product) |
| BI 695500BI 695500 375 mg/M2 | Drug | BI 695500 |
Primary outcome
Overall Response Measured as Overall Response Rate (ORR) at Week 30 for BI 695500 Versus Rituximab
Time frame: From first administration of study medication until 30 weeks thereafter.
The primary objective of this trial was to evaluate statistical equivalence of efficacy as assessed by Overall Response (measured as Overall Response Rate (ORR)) at Week 30 for treatment with BI 695500 versus rituximab (Rituxan®) in patients with untreated low tumor burden follicular lymphoma (LTBFL). The overall response measured as Overall Response Rate (ORR), which is the completed response (CR) and the partial response (PR) at Week 30, approximately 26 weeks after the completion of study treatment, as defined by International Working Group (IWG) criteria 2007 via an independent radiology assessment. Two patient were randomized and treated with BI 695500, whereas no patient was treated with rituximab in this trial.
2 secondary outcomes
Extrapolated Area Under the Concentration-time Curve of BI 695500 or Rituximab at Steady State Over the Interval 0 Hour (h) to the Next Dose of Trial Medication (AUC0-τ, ss)
Time frame: Sample timepoints Day 1, 8, 22, 23-24 (24-48 hours from start of Cycle 4 infusion), 24-26 (48-96 hours from start of Cycle 4 infusion), 26-36 (96-336 hours from start of Cycle 4 infusion), 78, 134, 204
Immunogenicity at Week 30
Time frame: Day 204 or end of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- 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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
21 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rituximab and BI 695500 in people with Lymphoma, Non-Hodgkin, run by Boehringer Ingelheim at 21 sites in 6 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 11 inclusion and 18 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 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Belgium, Bulgaria, Czechia, Austria and 1 more country. 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?
Yes. Results are posted in the registry (first posted 30 Jan 2017). 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?
Overall Response Measured as Overall Response Rate (ORR) at Week 30 for BI 695500 Versus Rituximab (time frame: From first administration of study medication until 30 weeks thereafter.). 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 30 Jan 2017.