0115: Bendamustine, Rituximab and 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 Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia.

• IRAS ID

  107805

• Contact name

  Peter Hillmen

• Sponsor organisation

  Gilead Sciences Inc.

• Eudract number

  2011-006292-20

• ISRCTN Number

  n/a

• Research summary

  Chronic Lymphocytic Leukaemia (CLL) is a serious and potentially life-threatening cancer primarily of older people. Standard treatment consists of rituximab often with other chemotherapy drugs such as bendamustine. While the bendamustine/rituximab combination offers benefit, CLL response is not universal and progressive disease eventually develops in all patients. This study is being done to test a new medicine called GS-1101, which is hoped can be successfully combined with bendamustine and rituximab in order to improve and prolong the control of CLL. So far GS-1101 has only been given to patients or healthy individuals in other clinical trials; it has been generally considered safe and well tolerated. All study participants will receive bendamustine and rituximab and will have an equal chance of being in one of 2 treatment groups: Group A: GS-1101 bendamustine/rituximab Group B: Placebo (dummy drug) bendamustine/rituximab Neither participants nor doctors will know which group is allocated. After 20 weeks of the above treatment, the bendamustine and rituximab will be stopped and participants will continue to take just the GS-1101 or placebo until their disease progresses (cancer gets worse/spreads) or they withdraw for another reason such as intolerable side effects. There will be 6 infusions of rituximab and 12 bendamustine infusions during the study. GS-1101 or placebo will be taken orally, twice daily, continuously. Study visits will be fortnightly for 24 weeks, with 6 additional visits for bendmustine infusions during this 24 weeks. Visits will then be every 6 weeks until Week 48, then every 12 weeks thereafter. Study visits will include blood tests, physical examinations and questionnaires. There will be CT or MRI scans every 12 weeks upto Week 120 and then at the end of treatment. This study is sponsored by Gilead, 390 patients will participate worldwide.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  12/YH/0318

• Date of REC Opinion

  10 Jul 2012

• REC opinion

  Favourable Opinion