Conditions: Chronic Lymphocytic Leukemia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 979
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Participants will receive obinutuzumab either alone as single agent or in combination with chemotherapy (Fludarabine/Cyclophosphamide \[FC\], Bendamustine or Chlorambucil) at the investigator's discretion. Each cycle is of 28-days duration.

Interventions: intervention 1: Bendamustine intervention 2: Chlorambucil intervention 3: Cyclophosphamide intervention 4: Fludarabine intervention 5: Obinutuzumab
Intervention descriptions: intervention 1: Bendamustine: 90 milligram per millilitre square (mg/m\^2) IV over 60 minutes once daily (QD) Day 1-2 in participants previously untreated or 70 mg/m\^2 I.V. over 60 minutes QD Day 1-2 in participants with relapsed/refractory disease. In non-fit participants only, investigators may opt at their own discretion to use lower initial doses of bendamustine, i.e., bendamustine 70 mg/m\^2 in previously untreated participants, and bendamustine 50 mg/m\^2 in relapsed/refractory subjects (over 60 minutes qd Day 1-2 for each administration). intervention 2: Chlorambucil 0.5 mg/kg p.o. qd on Day 1 and Day 15 in non-fit participants only. intervention 3: Cyclophosphamide 250 mg/m\^2 I.V. over 15-30 minutes qd Day 1-3 or Cyclophosphamide 250 mg/m\^2 p.o. QD Day 1-3 in fit participants only. intervention 4: Fludarabine 25 mg/m\^2 I.V. over 30 minutes QD Day 1-3 or Fludarabine 40 mg/m\^2 per os (p.o.) QD Day 1-3 in fit participants only. intervention 5: Participants will receive obinutuzumab 1000 mg IV infusion on Days 1/2 (dose split over 2 consecutive days; 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1, and on Day 1 of Cycles 2, 3, 4, 5, and 6. Each cycle is of 28-days duration.

Protocol document: