A Study of Navitoclax in Addition to Bendamustine and Rituximab in Patients With Relapsed Diffuse Large B-Cell Lymphoma (NAVIGATE)
NCT ID: NCT01423539
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2011-10-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
bendamustine
Intravenous repeating dose\\n
rituximab
Intravenous repeating dose\\n
B
bendamustine
Intravenous repeating dose\\n
navitoclax
Oral repeating dose\\n
rituximab
Intravenous repeating dose\\n
Interventions
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bendamustine
Intravenous repeating dose\\n
navitoclax
Oral repeating dose\\n
rituximab
Intravenous repeating dose\\n
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Fountain Valley, California, United States
Hudson, Florida, United States
Lawrenceville, Georgia, United States
Centralia, Illinois, United States
Harvey, Illinois, United States
Terre Haute, Indiana, United States
Hazard, Kentucky, United States
Paducah, Kentucky, United States
Rockville, Maryland, United States
Jefferson City, Missouri, United States
Great Falls, Montana, United States
Newark, Ohio, United States
Nashville, Tennessee, United States
Countries
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Other Identifiers
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GP27814
Identifier Type: -
Identifier Source: org_study_id