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

• Sponsor: Genentech, Inc. (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT01423539
• Collaborator: AbbVie (prior sponsor, Abbott) (Industry)
• Enrollment: 0
• Locations: 13
• Arms: 2
• Duration (Months): 28.1
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B-Cell Lymphoma	Drug: bendamustine; Drug: navitoclax; Drug: rituximab	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Oct 1, 2011
• Anticipated Primary Completion Date: Feb 1, 2014
• Anticipated Study Completion Date: Feb 1, 2014

Arms and Interventions

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: navitoclax; Oral repeating dose\n; Drug: rituximab; Intravenous repeating dose\n

Outcome Measures

Primary Outcome Measures

1. Progression-free survival (time from randomization to progression, relapse or death of any cause) [up to approximately 33 months]

Secondary Outcome Measures

1. Clinical response rates (complete response/partial response/stable disease) [approximately 33 months]

2. Duration of response [approximately 33 months]

3. Overall survival [approximately 33 months]

4. Safety: Incidence of adverse events [approximately 33 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Fountain Valley	California	United States	92708
2		Hudson	Florida	United States	34667
3		Lawrenceville	Georgia	United States	30045
4		Centralia	Illinois	United States	62801
5		Harvey	Illinois	United States	60426
6		Terre Haute	Indiana	United States	47802
7		Hazard	Kentucky	United States	41701
8		Paducah	Kentucky	United States	42003
9		Rockville	Maryland	United States	20850
10		Jefferson City	Missouri	United States	65109
11		Great Falls	Montana	United States	59405
12		Newark	Ohio	United States	43055
13		Nashville	Tennessee	United States	37203

Sponsors and Collaborators

• Genentech, Inc.
• AbbVie (prior sponsor, Abbott)

Investigators

• Study Director: Clinical Trials, Genentech, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT01423539
• Other Study ID Numbers: GP27814
• First Posted: Aug 26, 2011
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Rituximab; Bendamustine Hydrochloride; Navitoclax

Study Results

No Results Posted as of Nov 2, 2016