Diffuse Large B-Cell LymphomaPhase 2NCT01423539
A Study of Navitoclax in Addition to Bendamustine and Rituximab in Patients With Relapsed Diffuse Large B-Cell Lymphoma (NAVIGATE)
A Phase 2 study testing bendamustine, navitoclax and rituximab in people with Diffuse Large B-Cell Lymphoma, run by Genentech, Inc. at 13 sites in United States.
Trial summary
This randomized, open-label, multicenter study will evaluate the efficacy and safety of navitoclax in addition to bendamustine and rituximab in patients with relapsed diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- bendamustine, navitoclax 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
- 0 participants
- Where
- 13 sitesUnited States
- Study dates
- Oct 2011to Feb 2014
- Phase
- Phase 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
- Histologically documented diagnosis of diffuse large B-cell lymphoma
- Patients must have relapsed or developed progressive disease following salvage therapy, or must have relapsed or progressed following initial therapy and in the opinion of the investigator are medically unfit to receive high dose chemotherapy with autologous stem cell transplant (SCT) or other salvage therapy of higher priority
- Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Patients who have undergone STC must be more than 100 days from autologous stem cell infusion prior to first dose of study drug, must have recovered from any transplant related toxicity and must have adequate bone marrow function as defined by protocol independent of any growth factor support
- Patients who have not undergone SCT must have adequate bone marrow function as defined by protocol independent of any growth factor support
- Adequate coagulation, renal and hepatic function
Who cannot join
- Refractory DLBCL
- History of other malignancies within 2 years prior to initiation of study treatment except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin carcinoma, low-grade localized prostate cancer treated surgically with curative intent or one that carries a good prognosis, in situ ductal carcinoma of the breast treated with lumpectomy (with and without radiation) with curative intent
- Active infection requiring parenteral antibiotics or antiviral or antifungal agents
- Inherited or acquired bleeding diathesis, anticoagulant drugs or drugs that inhibit platelet function, underlying conditions that predisposes to abnormal bleeding, or refractoriness to platelet transfusions
- Clinically significant cardiovascular disease, New York Heart Association Grade II or greater congestive heart failure, or ventricular tachyarrhythmias requiring medication within 1 year prior to the initiation of study treatment
- Positive for hepatitis B, hepatitis C or HIV infection
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Study site
Centralia, Illinois, 62801
Study site
Fountain Valley, California, 92708
Study site
Great Falls, Montana, 59405
Study site
Harvey, Illinois, 60426
Study site
Hazard, Kentucky, 41701
Study site
Hudson, Florida, 34667
Study site
Jefferson City, Missouri, 65109
Study site
Lawrenceville, Georgia, 30045
Study site
Nashville, Tennessee, 37203
Study site
Newark, Ohio, 43055
Study site
Paducah, Kentucky, 42003
Study site
Rockville, Maryland, 20850
Study site
Terre Haute, Indiana, 47802
About this study
Official title: A Phase II, Multicenter, Randomized, Controlled, Open-Label Study of Bendamustine + Rituximab With or Without Navitoclax in Patients With Relapsed Diffuse Large B-Cell Lymphoma
This randomized, open-label, multicenter study will evaluate the efficacy and safety of navitoclax in addition to bendamustine and rituximab in patients with relapsed diffuse large B-cell lymphoma. Patients will be randomized to receive navitoclax in addition to bendamustine and rituximab or bendamustine and rituximab alone for 6 cycles.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- bendamustine, navitoclax, rituximab
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bendamustineDrug
Intravenous repeating dose\n
navitoclaxDrug
Oral repeating dose\n
rituximabDrug
Intravenous repeating dose\n
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: bendamustine; Drug: rituximab |
| B | Experimental | Not described Receives: Drug: bendamustine; Drug: navitoclax; Drug: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (time from randomization to progression, relapse or death of any cause)
Measured: up to approximately 33 months
Secondary outcomes (4)
Clinical response rates (complete response/partial response/stable disease)
Measured: approximately 33 months
Duration of response
Measured: approximately 33 months
Overall survival
Measured: approximately 33 months
Safety: Incidence of adverse events
Measured: approximately 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Why it stopped: The NAVIGATE study has been terminated due to non-safety related reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AbbVie (prior sponsor, Abbott)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423539
- Sponsor's protocol ID
- GP27814
- Status last verified
- Nov 2016
- First submitted
- 24 Aug 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Controlled, Open-Label Study of Bendamustine + Rituximab With or Without Navitoclax in Patients With Relapsed Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01423539
- Acronym / sponsor ID
- GP27814
- Conditions
- Diffuse Large B-Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The NAVIGATE study has been terminated due to non-safety related reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AbbVie (prior sponsor, Abbott)
- Study start
- Oct 2011
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 26 Aug 2011 (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 randomized, open-label, multicenter study will evaluate the efficacy and safety of navitoclax in addition to bendamustine and rituximab in patients with relapsed diffuse large B-cell lymphoma. Patients will be randomized to receive navitoclax in addition to bendamustine and rituximab or bendamustine and rituximab alone for 6 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: bendamustine, Drug: rituximab |
| B | Experimental | Drug: bendamustine, Drug: navitoclax, Drug: rituximab |
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 diagnosis of diffuse large B-cell lymphoma
- Patients must have relapsed or developed progressive disease following salvage therapy, or must have relapsed or progressed following initial therapy and in the opinion of the investigator are medically unfit to receive high dose chemotherapy with autologous stem cell transplant (SCT) or other salvage therapy of higher priority
- Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Patients who have undergone STC must be more than 100 days from autologous stem cell infusion prior to first dose of study drug, must have recovered from any transplant related toxicity and must have adequate bone marrow function as defined by protocol independent of any growth factor support
- Patients who have not undergone SCT must have adequate bone marrow function as defined by protocol independent of any growth factor support
Key exclusion criteria (6 listed)
- Refractory DLBCL
- History of other malignancies within 2 years prior to initiation of study treatment except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin carcinoma, low-grade localized prostate cancer treated surgically with curative intent or one that carries a good prognosis, in situ ductal carcinoma of the breast treated with lumpectomy (with and without radiation) with curative intent
- Active infection requiring parenteral antibiotics or antiviral or antifungal agents
- Inherited or acquired bleeding diathesis, anticoagulant drugs or drugs that inhibit platelet function, underlying conditions that predisposes to abnormal bleeding, or refractoriness to platelet transfusions
- Clinically significant cardiovascular disease, New York Heart Association Grade II or greater congestive heart failure, or ventricular tachyarrhythmias requiring medication within 1 year prior to the initiation of study treatment
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 |
|---|---|---|
| bendamustineIntravenous repeating dose\n | Drug | A, B |
| navitoclaxOral repeating dose\n | Drug | B |
| rituximabIntravenous repeating dose\n | Drug | A, B |
Primary outcome
Progression-free survival (time from randomization to progression, relapse or death of any cause)
Time frame: up to approximately 33 months
4 secondary outcomes
Clinical response rates (complete response/partial response/stable disease)
Time frame: approximately 33 months
Duration of response
Time frame: approximately 33 months
Overall survival
Time frame: approximately 33 months
Safety: Incidence of adverse events
Time frame: approximately 33 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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.
Clinical Trials study director
Genentech, Inc.
13 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 bendamustine, navitoclax and rituximab in people with Diffuse Large B-Cell Lymphoma, run by Genentech, Inc. at 13 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: withdrawn, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Progression-free survival (time from randomization to progression, relapse or death of any cause) (time frame: up to approximately 33 months). 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 Nov 2016.