A Study of Obinutuzumab (GA101; RO5072759) in Combination With Chemotherapy in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GALTON)

PHASE1CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

January 31, 2013

Study Completion Date

December 31, 2015

Conditions
Lymphocytic Leukemia, Chronic
Interventions
DRUG

Fludarabine

Participants will receive 6 cycles (each 28-day cycle) of fludarabine at dose of 25 mg/m\^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6.

DRUG

Obinutuzumab

Participants will receive 6 cycles (each 28-day cycle) of obinutuzumab at dose of 1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6.

DRUG

Bendamustine

Participants will receive 6 cycles (each 28-day cycle) of bendamustine at dose of 90 mg/m\^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6.

DRUG

Cyclophosphamide

Participants will receive 6 cycles (each 28-day cycle) of cyclophosphamide at dose of 250 mg/m\^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6.

Trial Locations (18)

14642

Rochester

30060

Marietta

30322

Atlanta

35805

Huntsville

53705

Madison

55426

Saint Louis Park

60637

Chicago

65807

Springfield

77030

Houston

90095

Los Angeles

91010

Duarte

92093

La Jolla

98109

Seattle

98405

Tacoma

06489

Southington

33612-9497

Tampa

02115

Boston

02114

Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY