A Study of Navitoclax in Addition to Bendamustine and Rituximab in Patients With Relapsed Diffuse Large B-Cell Lymphoma (NAVIGATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01423539
Recruitment Status : Withdrawn (The NAVIGATE study has been terminated due to non-safety related reasons.)
First Posted : August 26, 2011
Last Update Posted : November 2, 2016
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
Genentech, Inc.

Brief 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. Patients will be randomized to receive navitoclax in addition to bendamustine and rituximab or bendamustine and rituximab alone for 6 cycles.

Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma Drug: bendamustine Drug: navitoclax Drug: rituximab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2011
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Arm Intervention/treatment
Active Comparator: A Drug: bendamustine
Intravenous repeating dose\n

Drug: rituximab
Intravenous repeating dose\n

Experimental: B Drug: bendamustine
Intravenous repeating dose\n

Drug: navitoclax
Oral repeating dose\n

Drug: rituximab
Intravenous repeating dose\n

Primary Outcome Measures :
  1. Progression-free survival (time from randomization to progression, relapse or death of any cause) [ Time Frame: up to approximately 33 months ]

Secondary Outcome Measures :
  1. Clinical response rates (complete response/partial response/stable disease) [ Time Frame: approximately 33 months ]
  2. Duration of response [ Time Frame: approximately 33 months ]
  3. Overall survival [ Time Frame: approximately 33 months ]
  4. Safety: Incidence of adverse events [ Time Frame: approximately 33 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01423539

United States, California
Fountain Valley, California, United States, 92708
United States, Florida
Hudson, Florida, United States, 34667
United States, Georgia
Lawrenceville, Georgia, United States, 30045
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
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, Inc.
AbbVie (prior sponsor, Abbott)
Study Director: Clinical Trials Genentech, Inc.

Responsible Party: Genentech, Inc. Identifier: NCT01423539     History of Changes
Other Study ID Numbers: GP27814
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Bendamustine Hydrochloride
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action