NCT00532129

A Study of MabThera (Rituximab) Plus Chlorambucil in Participants With Chronic Lymphocytic Leukemia.

An Open-Label Study to Characterize the Safety and Response Rate of MabThera (Rituximab) Plus Chlorambucil in Previously Untreated Patients With CD20-Positive B-Cell Chronic Lymphocytic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This single arm study will assess the safety and effect on response rate of a combination of rituximab and chlorambucil in previously untreated participants with B-cell chronic lymphocytic leukemia. Participants will receive 6 monthly cycles of combination treatment, followed by up to 6 cycles of chlorambucil alone. Rituximab will be administered on Day 1 of each cycle, at a dose of 375 milligrams per square meter (mg/m\^2) intravenously (IV) in Cycle 1, and 500 mg/m\^2 in subsequent cycles, and chlorambucil will be administered on Days 1-7 of each cycle at a dose of 10 mg/m\^2/day per oral (PO).

Conditions

• Lymphocytic Leukemia, Chronic

Interventions

Type	Name	Description
DRUG	Rituximab	375mg/m\^2 IV on Day 1 of Cycle 1; 500mg/m\^2 on Day 1 of Cycles 2-6.
DRUG	Chlorambucil	10 mg/m\^2/day PO on Days 1 to 7 of each cycle for a maximum of 12 cycles.

Timeline

• Start date: 2007-11-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2007-09-19
• Last updated: 2016-04-06
• Results posted: 2016-04-06

Locations

12 sites across 1 country: United Kingdom