A Study of Obinutuzumab(GA101) in Combination With High-Dose Methylprednisolone(HDMP) in Chronic Lymphocytic Leukemia(CLL) Patients (GA101 & HDMP)

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

October 30, 2025

Study Completion Date

December 25, 2025

Conditions
CLL
Interventions
DRUG

GA101/HDMP

"All subjects will receive GA101 - Obinutuzumab by IV infusion for up to 6 cycles (28-day cycles) as follow:~* On Cycle 1, Day 1, 100 mg GA101-obinutuzumab will be administered.~* On Cycle 1, Day 2, 900 mg of GA101-obinutuzumab will be administered.~* On Cycle 1, Days 8 and 15, 1,000 mg of GA101-obinutuzumab will be administered.~* On Cycles 2-6, Day 1, 1,000 mg of GA101-obinutuzumab will be administered.~All subjects will receive HDMP by IV infusion for up to 4 cycles (28-day cycles) as follow:~•On Cycle 1-4, Days 1 to 3, 1,000 mg/m2 Methylprednisolone will be administered."

Trial Locations (1)

92093

UCSD Moores Cancer Center, La Jolla

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

University of California, San Diego

OTHER