NCT01087151

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)

A Phase II, Multicenter, Randomized, Controlled, Open-label Study of the Safety, Efficacy and Pharmacokinetics 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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	ABT-263	Oral repeating dose
DRUG	rituximab	Intravenous repeating dose

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-03-16
• Last updated: 2016-11-02

Locations

103 sites across 12 countries: United States, Australia, Brazil, Czechia, France, Israel, Italy, Poland, Puerto Rico, Russia, Ukraine, United Kingdom