Clinical trial NCT01423539: A Study of Navitoclax in Addition to Bendamustine and Rituximab in Patients With Relapsed Diffuse Large B-Cell Lymphoma (NAVIGATE)
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Diffuse Large B-Cell Lymphoma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: AbbVie (prior sponsor, Abbott)
First posted: 2011-08-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Progression-free survival (time from randomization to progression, relapse or death of any cause)
timeFrame: up to approximately 33 months
Secondary outcomes:
measure: Clinical response rates (complete response/partial response/stable disease)
timeFrame: approximately 33 months
measure: Duration of response
timeFrame: approximately 33 months
measure: Overall survival
timeFrame: approximately 33 months
measure: Safety: Incidence of adverse events
timeFrame: approximately 33 months
Other outcomes:
Locations:
city: Fountain Valley
country: United States
state: California
city: Hudson
country: United States
state: Florida
city: Lawrenceville
country: United States
state: Georgia
city: Centralia
country: United States
state: Illinois
city: Harvey
country: United States
state: Illinois
city: Terre Haute
country: United States
state: Indiana
city: Hazard
country: United States
state: Kentucky
city: Paducah
country: United States
state: Kentucky
city: Rockville
country: United States
state: Maryland
city: Jefferson City
country: United States
state: Missouri
city: Great Falls
country: United States
state: Montana
city: Newark
country: United States
state: Ohio
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: