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This study has been withdrawn prior to enrollment.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. )

First Received on August 24, 2011. Last Updated on April 3, 2012 History of Changes

Sponsor:	Genentech
Collaborator:	Abbott
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT01423539

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:

MedlinePlus related topics: Lymphoma

Drug Information available for: Bendamustine hydrochloride Bendamustine Rituximab

U.S. FDA Resources

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 20, 2012