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

NCT01423539 | Withdrawn Phase 2

• 1 other identifier: GP27814
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 13

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.

Conditions

Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (time from randomization to progression, relapse or death of any cause)

  up to approximately 33 months

Secondary Outcomes (4)

• Clinical response rates (complete response/partial response/stable disease)

  approximately 33 months

• Duration of response

  approximately 33 months

• Overall survival

  approximately 33 months

• Safety: Incidence of adverse events

  approximately 33 months

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: bendamustine; Drug: rituximab

B

EXPERIMENTAL

Drug: bendamustine; Drug: navitoclax; Drug: rituximab

Interventions

bendamustine DRUG

Intravenous repeating dose\\n

A; B

navitoclax DRUG

Oral repeating dose\\n

B

rituximab DRUG

Intravenous repeating dose\\n

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead
• AbbVie (prior sponsor, Abbott): collaborator

Study Sites (13)

Unknown Facility

Fountain Valley, California, 92708, United States

Location

Unknown Facility

Hudson, Florida, 34667, United States

Location

Unknown Facility

Lawrenceville, Georgia, 30045, United States

Location

Unknown Facility

Centralia, Illinois, 62801, United States

Location

Unknown Facility

Harvey, Illinois, 60426, United States

Location

Unknown Facility

Terre Haute, Indiana, 47802, United States

Location

Unknown Facility

Hazard, Kentucky, 41701, United States

Location

Unknown Facility

Paducah, Kentucky, 42003, United States

Location

Unknown Facility

Rockville, Maryland, 20850, United States

Location

Unknown Facility

Jefferson City, Missouri, 65109, United States

Location

Unknown Facility

Great Falls, Montana, 59405, United States

Location

Unknown Facility

Newark, Ohio, 43055, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Bendamustine Hydrochloride; navitoclax; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: August 26, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (13)