A Study of Navitoclax in Addition to Bendamustine and Rituximab in Patients With Relapsed Diffuse Large B-Cell Lymphoma (NAVIGATE)
This study has been withdrawn prior to enrollment.
(The NAVIGATE study has been terminated due to non-safety related reasons.)
Sponsor:
Genentech
Collaborator:
Abbott
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT01423539
First received: August 24, 2011
Last updated: April 3, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, B-Cell |
Drug: navitoclax Drug: bendamustine Drug: rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Progression-free survival (time from randomization to progression, relapse or death of any cause) [ Time Frame: up to approximately 33 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical response rates (complete response/partial response/stable disease) [ Time Frame: approximately 33 months ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: approximately 33 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: approximately 33 months ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: approximately 33 months ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: A |
Drug: bendamustine
Intravenous repeating dose\n
Drug: rituximab
Intravenous repeating dose\n
|
| Experimental: B |
Drug: navitoclax
Oral repeating dose\n
Drug: bendamustine
Intravenous repeating dose\n
Drug: rituximab
Intravenous repeating dose\n
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423539
Locations
| United States, California | |
| Fountain Valley, California, United States, 92708 | |
| United States, Florida | |
| Hudson, Florida, United States, 34667 | |
| United States, Georgia | |
| Lawrenceville, Georgia, United States, 30046 | |
| United States, Illinois | |
| Centralia, Illinois, United States, 62801 | |
| Harvey, Illinois, United States, 60426 | |
| United States, Indiana | |
| Terre Haute, Indiana, United States, 47802 | |
| United States, Kentucky | |
| Hazard, Kentucky, United States, 41701 | |
| Paducah, Kentucky, United States, 42003 | |
| United States, Maryland | |
| Rockville, Maryland, United States, 20850-3348 | |
| United States, Missouri | |
| Jefferson City, Missouri, United States, 65109 | |
| United States, Montana | |
| Great Falls, Montana, United States, 59405 | |
| United States, Ohio | |
| Newark, Ohio, United States, 43055 | |
| United States, Tennessee | |
| Nashville, Tennessee, United States, 37203 | |
Sponsors and Collaborators
Genentech
Abbott
Investigators
| Study Director: | Clinical Trials | Genentech |
More Information
No publications provided
| Responsible Party: | Disclosures Group, Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT01423539 History of Changes |
| Other Study ID Numbers: | GP27814 |
| Study First Received: | August 24, 2011 |
| Last Updated: | April 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Bendamustine Rituximab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 21, 2013