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

Diffuse Large B-Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01423539
• Other study ID #: GP27814
• Status: Withdrawn
• Phase: Phase 2
• First received: August 24, 2011
• Last updated: November 1, 2016
• Start date: October 2011
• Est. completion date: February 2014

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• bendamustine
Intravenous repeating dose\n
• navitoclax
Oral repeating dose\n
• rituximab
Intravenous repeating dose\n

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Genentech, Inc.	AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (time from randomization to progression, relapse or death of any cause)		up to approximately 33 months	No
Secondary	Clinical response rates (complete response/partial response/stable disease)		approximately 33 months	No
Secondary	Duration of response		approximately 33 months	No
Secondary	Overall survival		approximately 33 months	No
Secondary	Safety: Incidence of adverse events		approximately 33 months	No