0116: Phase 3 study of Rituximab & GS-1101 or placebo in CLL

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS 1101 (CAL-101) in Combination with Rituximab for Previously Treated Chronic Lymphocytic Leukemia

• IRAS ID

  100919

• Contact name

  Peter Hillmen

• Sponsor organisation

  Gilead Sciences Inc.

• Eudract number

  2011-005180-24

• ISRCTN Number

  n/a

• Research summary

  Chronic Lymphocytic Leukaemia is a serious and potentially life-threatening cancer primarily of older people. Standard treatment consists of rituximab often with other chemotherapy drugs. Rituximab is usually well tolerated (side effects tend to be mild), but the companion chemotherapy is often too toxic or less effective for older patients or those with co-existing medical conditions. This study is being done to test a new medicine called GS-1101, which is hoped will be an effective, well tolerated option for patients unable to receive chemotherapy. So far GS-1101 has only been given to patients or healthy individuals in other clinical trials; it has been considered safe and well tolerated. All study participants will receive rituximab and will have an equal chance of being in one of 2 treatment groups: Group A: standard dose GS-1101 rituximab Group B: Placebo (dummy drug) rituximab Neither participants nor doctors will know which group is allocated. There will be 8 infusions of rituximab and GS-1101 or placebo will be taken orally, twice daily, continuously. Participants will continue in the study until their disease progresses (cancer gets worse/spreads) or they withdraw for another reason such as intolerable side effects. Participants with disease progression will have the option to enter an extension study in which all participants receive GS-1101; Group A will receive a higher dose and Group B will receive the standard dose. Study visits will be fortnightly for 12 weeks, then 4 weekly until Week 24, every 6 weeks to Week 48 then every 12 weeks. Study visits will include blood tests, physical examinations and questionnaires. There will be CT or MRI scans at Weeks 8, 16, 24, 36 and 48, every 12 weeks upto Week 96 and then at the end of treatment. This study is sponsored by Gilead, 160 patients will participate worldwide.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  12/YH/0178

• Date of REC Opinion

  8 May 2012

• REC opinion

  Favourable Opinion