Open label study of PCI-32765 vs Chlorambucil in CLL/SLL

• Research type

  Research Study

• Full title

  A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton’s Tyrosine Kinase Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

• IRAS ID

  119604

• Contact name

  Peter Hillmen

• Sponsor organisation

  Pharmacyclics, Incorporated

• Eudract number

  2012-003967-23

• Clinicaltrials.gov Identifier

  NCT01722487

• Research summary

  Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma is a serious and potentially life-threatening cancer primarily of older people. Standard treatment options are often too toxic or less effective for older patients. This study is being done to test a new medicine called PCI-32765, which is hoped will be a safe and effective option for older patients. So far PCI-32765 has only been given to patients or healthy people in other clinical trials; it has been considered safe and well tolerated. This study will compare PCI-32765 to the standard treatment, chlorambucil.Study participants will have an equal chance of being in one of 2 groups:?½ Group A: Oral chlorambucil 0.5 mg/kg on Days 1 and 15 of each 28-day cycle (dose may be increased). Patients will receive minimum of 3 and maximum of 12 cycles?½ Group B: Oral PCI-32765 420 mg/day until progressive disease or unacceptable side effectsTreatment groups will be assigned randomly (by a computer); participants and their doctors will know which treatment they are receiving. Participants will continue in the study until the study stops, their disease progresses (cancer gets worse/spreads) or they withdraw for another reason such as intolerable side effects. Depending on their treatment group, participants will either continue to be followed up in this study or invited to join an extension study for further treatment and/or follow-up. Study visits will be fortnightly for the first 7 treatment cycles, then 4 weekly until disease progression. During follow-up, visits will be every 4 or 6 months. Study visits will include blood tests, physical examinations and questionnaires. There will be CT or MRI scans at screening and then every 4 months until month 25, then 6 monthly thereafter.This study is sponsored by Pharmacyclics; 272 participants aged 65 years or older will participate worldwide.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  13/YH/0011

• Date of REC Opinion

  20 Mar 2013

• REC opinion

  Further Information Favourable Opinion