Follicular LymphomaPhase 2NCT01980654
Study of Ibrutinib in Combination With Rituximab in Previously Untreated Subjects With Follicular Lymphoma
A Phase 2 study testing Ibrutinib and rituximab in people with Follicular Lymphoma and B-cell Lymphoma, run by Pharmacyclics LLC. at 12 sites in United States.
Trial summary
This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib combined with rituximab in previously untreated subjects with Follicular Lymphoma (FL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma, B-cell Lymphoma, Non-Hodgkin's Lymphoma
- What is being tested?
- Ibrutinib and rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 12 sitesUnited States
- Study dates
- Dec 2013to Nov 2017
- 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
- Histologically documented FL (Grade 1, 2 and 3A)
- Not previously treated with prior anti-cancer therapy for FL
- Stage II, III or IV disease
- At least one measurable lesion ≥ 2 cm in longest diameter by CT and/or MRI scan
- Men and women ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Who cannot join
- Medically apparent central nervous system lymphoma or leptomeningeal disease
- FL with evidence of large cell transformation
- Any prior history of other hematologic malignancy besides FL or myelodysplasia
- History of other malignancies, except
- Malignancy treated with curative intent and with no known active disease present for ≥5 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician.
- Adequately treated non-melanoma skin cancer or lentigomaligna without evidence of disease.
Show all 12Show fewer
- Adequately treated carcinoma in situ without evidence of disease.
- Currently active, clinically significant cardiovascular disease or myocardial infarction within 6 months of screening
- Known anaphylaxis or Immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab (Rituxan®)
- Requires anti-coagulation with warfarin or a vitamin K antagonist.
- Requires treatment with strong cytochrome P450 (CYP) 3A inhibitors.
- Known bleeding diathesis or hemophilia
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Providence Saint Joseph Medical Center
Burbank, California, 91505
Mid-Ohio Oncology/ Hematology Inc
Columbus, Ohio, 43219
City of Hope
Duarte, California, 91010
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89074
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Community Health Network Community Regional Cancer Center North
Indianapolis, Indiana, 46256
UCLA Medical Center
Los Angeles, California, 90095
Tennessee Oncology, PLLC The Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medical College New York-Presbyterian Hospital
New York, New York, 10065
Southeastern Regional Medical Center
Newnan, Georgia, 30265
Stanford University, Stanford Care Center
Stanford, California, 94305
About this study
Official title: A Multicenter, Open-Label, Phase 2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab in Previously Untreated Subjects With Follicular Lymphoma
This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib combined with rituximab in previously untreated subjects with Follicular Lymphoma (FL).
Read the detailed description
This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib combined with rituximab in previously untreated subjects with FL.
There are two study treatment arms.
Subjects enrolled into main study treatment arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment.
Subjects enrolled into the exploratory study treatment arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. After the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity.
- Conditions
- Follicular Lymphoma, B-cell Lymphoma, Non-Hodgkin's Lymphoma
- Keywords
- Pharmacyclics (PCYC), PCYC, Lymphoma, Follicular Lymphoma, FL, Rituximab, Ibrutinib, Rituxan, Non-Hodgkin's Lymphoma (NHL), NHL, B-cell Lymphoma
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
Also called PCI-32765
All subjects will receive 560 mg of Ibrutinib orally.
rituximabDrug
Also called Rituxan
All subjects will receive rituximab 375 mg/m2 intravenously
| Study group | Role | What they receive |
|---|---|---|
| Main Study Arm 1 | Experimental | Subjects enrolled into this arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment. Receives: Drug: Ibrutinib; Drug: rituximab |
| Exploratory Study Arm 2 | Experimental | Subjects enrolled into this arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. After the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity. Receives: Drug: Ibrutinib; Drug: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR): Proportion of Subjects Achieving the Best Overall Responses of Complete Response (CR) or Partial Response (PR)
Number of subjects achieving the best overall responses of CR or PR prior to the initiation of the next line of antineoplastic therapy as assessed by investigator per the Cheson et al, 2007 criteria. Target lesions are measured by CT, unless MRI is used as the assessment modality for lesions in anatomical locations not amenable to CT. CR is defined as the disappearance of all evidence of disease. PR is defined as >=50% decrease in the sum of the product of the diameters of up to 6 largest dominant masses.
Measured: Subjects in Arm 1 will have imaging assessments every 12 weeks for the first 8 assessments, then every 24 weeks. Subjects in Arm 2 will have imaging assessments starting at week 9, then every 12 weeks for 8 assessments, then every 24 weeks.
Secondary outcomes (4)
Duration of Response (DOR)
DOR is defined as the interval between the date of the first documented response (CR, PR) and the date of the first documented evidence of progressive disease (PD) or death. DOR will be analyzed for the subjects who achieve an overall response during the duration of study.
Measured: Up to 45 months
Progression Free Survival (PFS)
PFS is defined as the time interval between the date of the first dose and the date of the earliest occurrence of PD or death due to any cause, whichever occurs first. PD is characterized by any new lesion or increase by >=50% of previously involved sites from nadir.
Measured: Up to 45 months
Overall Survival (OS)
Subjects will be followed for survival information up to three years after the last dose of study treatment, until new treatment or death, whichever occurs first. OS is defined as the duration of time from the date of the first dose to the date of death from any cause.
Measured: Up to 45 months
Number of Participants With Treatment-emergent Adverse Events
Frequency, severity, and relatedness of treatment-emergent adverse events (AEs) Frequency of treatment-emergent AEs requiring discontinuation of study drug or dose reductions
Measured: Up to 45 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionNov 2017
- Study completionNov 2017
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 Follicular LymphomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacyclics LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jutta K. Neuenburg, MD, PhD, Study director, Pharmacyclics LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980654
- Sponsor's protocol ID
- PCYC-1125-CA
- Status last verified
- Mar 2019
- First submitted
- 24 Oct 2013
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase 2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab in Previously Untreated Subjects With Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT01980654
- Acronym / sponsor ID
- PCYC-1125-CA
- Conditions
- Follicular Lymphoma, B-cell Lymphoma, Non-Hodgkin's Lymphoma
- Keywords
- Pharmacyclics (PCYC), PCYC, Lymphoma, Follicular Lymphoma, FL, Rituximab, Ibrutinib, Rituxan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pharmacyclics LLC.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Posted 16 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib combined with rituximab in previously untreated subjects with Follicular Lymphoma (FL).
Detailed description
This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib combined with rituximab in previously untreated subjects with FL.
There are two study treatment arms.
Subjects enrolled into main study treatment arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment.
Subjects enrolled into the exploratory study treatment arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. After the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main Study Arm 1 | Experimental | Drug: Ibrutinib, Drug: rituximabSubjects enrolled into this arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment. |
| Exploratory Study Arm 2 | Experimental | Drug: Ibrutinib, Drug: rituximabSubjects enrolled into this arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. After the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically documented FL (Grade 1, 2 and 3A)
- Not previously treated with prior anti-cancer therapy for FL
- Stage II, III or IV disease
- At least one measurable lesion ≥ 2 cm in longest diameter by CT and/or MRI scan
- Men and women ≥ 18 years of age
Key exclusion criteria (12 listed)
- Medically apparent central nervous system lymphoma or leptomeningeal disease
- FL with evidence of large cell transformation
- Any prior history of other hematologic malignancy besides FL or myelodysplasia
- History of other malignancies, except
- Currently active, clinically significant cardiovascular disease or myocardial infarction within 6 months of 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 |
|---|---|---|
| IbrutinibAlso: PCI-32765All subjects will receive 560 mg of Ibrutinib orally. | Drug | Exploratory Study Arm 2, Main Study Arm 1 |
| rituximabAlso: RituxanAll subjects will receive rituximab 375 mg/m2 intravenously | Drug | Exploratory Study Arm 2, Main Study Arm 1 |
Primary outcome
Overall Response Rate (ORR): Proportion of Subjects Achieving the Best Overall Responses of Complete Response (CR) or Partial Response (PR)
Time frame: Subjects in Arm 1 will have imaging assessments every 12 weeks for the first 8 assessments, then every 24 weeks. Subjects in Arm 2 will have imaging assessments starting at week 9, then every 12 weeks for 8 assessments, then every 24 weeks.
Number of subjects achieving the best overall responses of CR or PR prior to the initiation of the next line of antineoplastic therapy as assessed by investigator per the Cheson et al, 2007 criteria. Target lesions are measured by CT, unless MRI is used as the assessment modality for lesions in anatomical locations not amenable to CT. CR is defined as the disappearance of all evidence of disease. PR is defined as >=50% decrease in the sum of the product of the diameters of up to 6 largest dominant masses.
4 secondary outcomes
Duration of Response (DOR)
Time frame: Up to 45 months
Progression Free Survival (PFS)
Time frame: Up to 45 months
Overall Survival (OS)
Time frame: Up to 45 months
Number of Participants With Treatment-emergent Adverse Events
Time frame: Up to 45 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- 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.
Jutta K. Neuenburg, MD, PhD study director
Pharmacyclics LLC.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibrutinib and rituximab in people with Follicular Lymphoma and B-cell Lymphoma, run by Pharmacyclics LLC. at 12 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 12 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 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 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 16 Apr 2019). 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 Rate (ORR): Proportion of Subjects Achieving the Best Overall Responses of Complete Response (CR) or Partial Response (PR) (time frame: Subjects in Arm 1 will have imaging assessments every 12 weeks for the first 8 assessments, then every 24 weeks. Subjects in Arm 2 will have imaging assessments starting at week 9, then every 12 weeks for 8 assessments, then every 24 weeks.). 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 16 Apr 2019.