A Study of ABT-263 in Combination With Dose-Intensive Rituximab, or Dose-Intensive Rituximab Alone, in Previously Untreated Patients With B-Cell, Chronic Lymphocytic Leukemia (CLL)

Part of paid clinical trials in Alhambra, California.

Sponsor
Genentech, Inc.
Study ID
NCT01087151
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • ABT-263 — DRUG
    Oral repeating dose
  • rituximab — DRUG
    Intravenous repeating dose

Study Details

This Phase II, randomized, open-label, international, multicenter trial is designed to evaluate the safety and efficacy of rituximab monotherapy when given according to a dose intense regimen and to assess the safety, efficacy, and pharmacokinetics of ABT-263 when combined with dose-intense rituximab in previously untreated patients with B-cell CLL.

Key Dates

Start date
Aug 31, 2010
Status verified
Nov 2016
Primary completion
Jun 30, 2012
Completion
Jun 30, 2012

Study Design

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

Arms

  • Active Comparator: A
  • Experimental: B
  • Experimental: C

Primary Outcome Measure

Progression-free survival [ Time Frame: From randomization to the first occurrence of progression, relapse, or death on study (approximately 40 months from First Patient In [FPI]) ]

Locations (48)

FacilityCityStateZIPSite coordinators
-AlhambraCalifornia91801-
-AntiochCalifornia94531-
-BerkeleyCalifornia94704-
-BurbankCalifornia91505-
-DuarteCalifornia91010-
-DublinCalifornia94568-
-La JollaCalifornia92093-
-Los AngelesCalifornia90024-
-Los AngelesCalifornia90073-
-Los AngelesCalifornia90095-1772-
-Los AngelesCalifornia90095-
-NorthridgeCalifornia91325-
-Pleasant HillCalifornia94523-
-San LeandroCalifornia94578-2626-
-San Luis ObispoCalifornia93454-
-Santa MonicaCalifornia90404-
-Fort CollinsColorado80528-
-NorwalkConnecticut06856-
-Bay PinesFlorida33744-
-AtlantaGeorgia30322-
-ChicagoIllinois60612-
-DecaturIllinois62526-
-HarveyIllinois60426-
-Tinley ParkIllinois60477-
-ShreverportLouisiana71103-
-BaltimoreMaryland21215-
-BethesdaMaryland20817-
-BethesdaMaryland20874-
-RandallstownMaryland21133-
-LansingMichigan48909-
-LansingMichigan48912-
-OmahaNebraska68114-
-HendersonNevada89052-
-Las VegasNevada89148-
-Las VegasNevada89169-
-RenoNevada89502-
-Cherry HillNew Jersey08003-
-FarmingtonNew Mexico87401-
-OneidaNew York13421-
-OswegoNew York13126-
-SyracuseNew York13210-
-MiddletownOhio45042-
-PhiladelphiaPennsylvania19111-
-PittsburghPennsylvania15224-
-Corpus ChristiTexas78405-
-LubbockTexas79410-
-LubbockTexas79415-
-EverettWashington98201-

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