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

November 1, 2016 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fountain Valley, California, United States, 92708
    • Florida
      • Hudson, Florida, United States, 34667
    • Georgia
      • Lawrenceville, Georgia, United States, 30045
    • Illinois
      • Centralia, Illinois, United States, 62801
      • Harvey, Illinois, United States, 60426
    • Indiana
      • Terre Haute, Indiana, United States, 47802
    • Kentucky
      • Hazard, Kentucky, United States, 41701
      • Paducah, Kentucky, United States, 42003
    • Maryland
      • Rockville, Maryland, United States, 20850
    • Missouri
      • Jefferson City, Missouri, United States, 65109
    • Montana
      • Great Falls, Montana, United States, 59405
    • Ohio
      • Newark, Ohio, United States, 43055
    • Tennessee
      • Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: rituximab
Intravenous repeating dose\n
Drug: navitoclax
Oral repeating dose\n

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (time from randomization to progression, relapse or death of any cause)
Time Frame: up to approximately 33 months
up to approximately 33 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical response rates (complete response/partial response/stable disease)
Time Frame: approximately 33 months
approximately 33 months
Duration of response
Time Frame: approximately 33 months
approximately 33 months
Overall survival
Time Frame: approximately 33 months
approximately 33 months
Safety: Incidence of adverse events
Time Frame: approximately 33 months
approximately 33 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Collaborators

AbbVie (prior sponsor, Abbott)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

August 24, 2011

First Submitted That Met QC Criteria

August 24, 2011

First Posted (Estimate)

August 26, 2011

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GP27814

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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