A Phase I/II, Open-label Study of Ofatumumab Added to Chlorambucil in Previously Untreated Japanese Patients With Chronic Lymphocytic Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions
Leukaemia, Lymphocytic, Chronic
Interventions
DRUG

chlorambucil, tablets

2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles

DRUG

ofatumumab (GSK1841157) infusion

iv infusion; dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days;

Trial Locations (6)

466-8650

GSK Investigational Site, Aichi

060-8543

GSK Investigational Site, Hokkaido

259-1143

GSK Investigational Site, Kanagawa

602-8566

GSK Investigational Site, Kyoto

104-0045

GSK Investigational Site, Tokyo

135-8550

GSK Investigational Site, Tokyo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01563055 - A Phase I/II, Open-label Study of Ofatumumab Added to Chlorambucil in Previously Untreated Japanese Patients With Chronic Lymphocytic Leukemia | Biotech Hunter | Biotech Hunter