Efficacy & safety of GS-1101 with Ofatumumab in previously treated CLL
Research type
Research Study
Full title
A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of GS-1101 (CAL-101) in Combination with Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
IRAS ID
117270
Contact name
Finbar Cotter
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2012-001236-65
Clinicaltrials.gov Identifier
Research summary
A study evaluating efficacy and safety of GS-1101 in combination with Ofatumumab for previously treated Chronic Lymphocytic Leukaemia (CLL) patients. CLL is a cancer of the white blood cells which specifically affects B-lymphocytes (a type of white blood cell of the immune system). B lymphocytes originate in the bone marrow, develop in the lymph nodes, and normally fight infection in the body. In CLL, B-lymphocytes grow abnormally, accumulate in the blood, bone marrow, lymph nodes, spleen and liver, and interfere with normal-working blood cells. CLL is the most common type of leukaemia in Europe and the USA. This research study is evaluating an investigational (study) medication, called GS-1101, in combination with a standard medication, called Ofatumumab, as a possible treatment for CLL patients. The purpose of this study is to provide more information about whether giving Ofatumumab and GS-1101 together works better and is safer for treating people with CLL. The study will show if adding GS-1101 to a low dose of Ofatumumab will have a better effect on controlling CLL disease than giving a high dose of Ofatumumab alone. Approximately 210 patients from around the world will take part in the study. Participants will be divided into two groups. Group A receive Ofatumumab plus GS-1101 and group B Ofatumumab only. The participants will have a two out of three chance to receive the study medication treatment and they will be assigned to the groups by chance. Neither the participant nor the study doctor will be able to choose the group. All participants will receive a total of 12 infusions of Ofatumumab over ~24 weeks and continue to receive the GS-1101 or be observed for up to 5 years. The participants will have to provide blood and urine samples, undergo physical examinations, complete health-related questionnaires and perform other tests. In the UK the study will be conducted at NHS hospitals.
REC name
London - Riverside Research Ethics Committee
REC reference
13/LO/0002
Date of REC Opinion
18 Jan 2013
REC opinion
Favourable Opinion