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

Genentech

Status and phase

Withdrawn

Phase 2

Conditions

Diffuse Large B-Cell Lymphoma

Treatments

Drug: rituximab

Drug: navitoclax

Drug: bendamustine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01423539

GP27814

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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