Ofatumumab With Fludarabine and Cyclophosphamide in B-CLL Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

March 31, 2009

Study Completion Date

May 31, 2013

Conditions
Leukaemia, Lymphocytic, Chronic
Interventions
DRUG

Ofatumumab 500mg

Ofatumumab 500mg or should be diluted into 1000mL pyrogenefree saline and administered as an IV infusion.Duration of infusion will be approximately 6½ hours.Infusions should be given every 4 weeks until a total of 6 infusions has been given.

DRUG

Ofatumumab 1000mg

Ofatumumab 1000mg or should be diluted into 1000mL pyrogenefree saline and administered as an IV infusion.Duration of infusion will be approximately 6½ hours.Infusions should be given every 4 weeks until a total of 6 infusions has been given.

DRUG

Fludarabine

Fludarabine (25 mg/m2) should be administered as an IV infusion daily, Days 2 through 4 of Course 1, and Days 1 through 3 of Courses 2 through 6, every 4 weeks for 6 courses

DRUG

Cyclophosphamide

Cyclophosphamide (250 mg/m2) should be administered as an IV infusion daily, Days 2 through 4 of Course 1, and Days 1 through 3 of Courses 2 through 6, every 4 weeks for 6 courses.

Trial Locations (2)

77030

GSK Investigational Site, Houston

PL68DH

GSK Investigational Site, Plymouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY