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This study has been withdrawn prior to enrollment.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:
Collaborator:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01423539
First received: August 24, 2011
Last updated: April 14, 2014
Last verified: April 2014
  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
Study Start Date: October 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 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, 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
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01423539     History of Changes
Other Study ID Numbers: GP27814
Study First Received: August 24, 2011
Last Updated: April 14, 2014
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 April 17, 2014