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

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Genentech, Inc.
Study ID
NCT01423539
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bendamustine — DRUG
    Intravenous repeating dose\\n
  • navitoclax — DRUG
    Oral repeating dose\\n
  • rituximab — DRUG
    Intravenous repeating dose\\n

Study Details

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.

Key Dates

Start date
Oct 31, 2011
Status verified
Nov 2016
Primary completion
Feb 28, 2014
Completion
Feb 28, 2014

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: A
  • Experimental: B

Primary Outcome Measure

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

Locations (13)

FacilityCityStateZIPSite coordinators
-Fountain ValleyCalifornia92708-
-HudsonFlorida34667-
-LawrencevilleGeorgia30045-
-CentraliaIllinois62801-
-HarveyIllinois60426-
-Terre HauteIndiana47802-
-HazardKentucky41701-
-PaducahKentucky42003-
-RockvilleMaryland20850-
-Jefferson CityMissouri65109-
-Great FallsMontana59405-
-NewarkOhio43055-
-NashvilleTennessee37203-

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