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
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
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.
Inclusion Criteria:
Exclusion Criteria:
Additional exclusion criterion for Part 1:
Additional exclusion criterion for Part 2:
Passo Fundo, Rio Grande do Sul 99010-260, Brazil
Montreal, Quebec H3T 1E2, Canada
Hradec Králové, 500 05, Czechia
Prague, 128 08, Czechia
Berlin, 14195, Germany
Dresden, 01307, Germany
Greifswald, 17475, Germany
Hanover, 30171, Germany
Neunkirchen/Saar, 66538, Germany
Meldola, Emilia-Romagna 47014, Italy
Rimini, Emilia-Romagna 47900, Italy
Udine, Friuli Venezia Giulia 33100, Italy
Milan, Lombardy 20162, Italy
Novara, Piedmont 28100, Italy
Chihuahua City, 31000, Mexico
Lublin, 20-081, Poland
Moscow, 115478, Russia
Saint Petersburg, 197022, Russia
Istanbul, 34098, Turkey (Türkiye)