NCT01292603

A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia

An Adaptive, Comparative, Randomized, Parallel-group, Multi Center, Phase Ib Study of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With Chemotherapy (Fludarabine and Cyclophosphamide), in Patients With Previously Untreated CLL

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized, parallel-group, multi-center study will compare the pharmacokinetics and safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in combination with chemotherapy in previously untreated patients with chronic lymphocytic leukemia (CLL). The study consists of 2 parts. In part 1, patients who have previously received 4 cycles of intravenous MabThera will receive in Cycle 5 intravenous MabThera and in Cycle 6 subcutaneous MabThera. In part 2, patients will be randomized to receive either 6 cycles of intravenous MabThera, or 1 cycle of intravenous MabThera and 5 cycles of subcutaneous MabThera. Additionally, all patients will receive chemotherapy (fludarabine and cyclophosphamide) on Days 1-3 or Days 1-5 of every cycle. The anticipated time on study drug is 24 weeks.

Conditions

• Lymphocytic Leukemia, Chronic

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Days 1-3 or Days 1-5 of cycles 1-6
DRUG	Fludarabine	Days 1-3 or Days 1-5 of cycles 1-6
DRUG	rituximab [MabThera]	One cycle of intravenous MabThera, followed by 5 cycles of subcutaneous MabThera
DRUG	rituximab [MabThera]	After 4 cycles of intravenous MabThera without experiencing grade 3 or 4 infusion-related reactions. patients will receive 1 additional cycle of intravenous MabThera and 1 cycle of subcutaneous MabThera.
DRUG	rituximab [MabThera]	6 cycles of intravenous MabThera

Timeline

• Start date: 2011-04-18
• Primary completion: 2014-05-07
• Completion: 2017-11-17
• First posted: 2011-02-09
• Last updated: 2018-12-19
• Results posted: 2015-12-15

Locations

84 sites across 19 countries: Argentina, Australia, Brazil, Canada, Chile, Croatia, Czechia, France, Germany, Greece, Italy, Mexico, New Zealand, Poland, Portugal, Russia, Slovakia, Spain, Turkey (Türkiye)