A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL

PHASE2CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

October 6, 2020

Study Completion Date

October 6, 2020

Conditions
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Interventions
DRUG

Idelalisib

150 mg BID Oral Daily

DRUG

Ofatumumab

Ofatumumab will then be administered at 1000 mg weekly to complete 8 weeks (days 64, 71, 78, 85, 92, 99, 106) throughout Cycles 3 and 4. This will be followed by monthly ofatumumab on weeks 20, 24, 28, 32 to complete 4 additional cycles (5-8).

Trial Locations (3)

02114

Massachusetts General Hospital, Boston

02115

Beth Isreal Deaconess Medical Center, Boston

Dana-Farber Cancer Institute, Boston

Sponsors
All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

collaborator

GlaxoSmithKline

INDUSTRY

lead

Dana-Farber Cancer Institute

OTHER