A Multicenter, Open-Label, Single-Arm, Phase IIIb, International Study Evaluating the Safety of Obinutuzumab Alone or in Combination With Chemotherapy in Patients With Previously Untreated or Relapsed/Refractory Chronic Lymphocytic Leukemia
A Multicenter, Open-Label, Single-Arm, Phase IIIb, International Study Evaluating the Safety of Obinutuzumab Alone or in Combination With Chemotherapy in Patients With Previously Untreated or Relapsed/Refractory Chronic Lymphocytic Leukemia
This multicenter, open-label, single-arm study will evaluate the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in participants with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). This is a Post-Authorization Safety Study. Participants will receive 6 cycles of single-agent obinutuzumab or obinutuzumab in combination with chemotherapy at the investigator's discretion. Each participant will be followed until 30 months after the last participant has been enrolled. Total length of the study is anticipated to be approximately 5 years.
Inclusion Criteria:
Exclusion Criteria:
Banja Luka, 88000, Bosnia and Herzegovina
Greenfield Park, Quebec J4V 2H1, Canada
Québec, G1J 1Z4, Canada
Dresden, 01307, Germany
Frankfurt (Oder), 15236, Germany
Mutlangen, 73557, Germany
Neunkirchen/Saar, 66538, Germany
Regensburg, 93053, Germany
Ulm, 89081, Germany
Meldola, Emilia-Romagna 47014, Italy
Piacenza, Emilia-Romagna 29121, Italy
Rimini, Emilia-Romagna 47900, Italy
Rome, Lazio 00161, Italy
Milan, Lombardy 20162, Italy
Novara, Piedmont 28100, Italy
Turin, Piedmont 10126, Italy
Vilnius, 08661, Lithuania
Lublin, 20-081, Poland
Olsztyn, 10-228, Poland
Słupsk, 76-200, Poland
Saint Petersburg, 197341, Russia
Seoul, 03080, South Korea
Badalona, Barcelona 08915, Spain
Malmö, 212 24, Sweden
Aarau, 5001, Switzerland
Bangkok, 10330, Thailand
Chiang Mai, 50200, Thailand