Ibrutinib in Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma
Research type
Research Study
Full title
A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton’s Tyrosine Kinase Inhibitor Ibrutinib in Combination with Obinutuzumab versus Chlorambucil in Combination with Obinutuzumab in Subjects with Treatment-naive Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma Protocol No: PCYC-1130-CA
IRAS ID
162429
Contact name
Peter Hillmen
Contact email
Sponsor organisation
Pharmacyclics, Incorporated
Eudract number
2014-002069-31
Research summary
This is a Phase 3, multicenter, randomised, open label study of oral ibrutinib in combination with intravenous obinutuzumab versus oral chlorambucil in combination with intravenous obinutuzumab in subjects with treatment-naive chronic lymphocytic leukaemia (CLL)or small lymphocytic lymphoma (SLL).
212 eligible subjects will be randomised in a 1:1 ratio to Treatment Arm A or Arm B.
Arm A: (Ibrutinib + Obinutuzumab)
Oral ibrutinib 420mg daily in combination with obinutuzumab 1000 mg intravenously over 6 cycles.Arm B: (Chlorambucil + Obinutuzumab)
Treatment will be 6 cycles. Chlorambucil will be administered orally at a dose of 0.5 mg/kg body weight, on Days 1 and 15 of each cycle. Obinutuzumab will be administered intravenously at a dose of 1000 mg, over 6 cycles. Subjects randomised to Arm B who experience confirmed disease progression will be eligible for access to next-line ibrutinib (cross-over) therapy.During the pre-progressive disease phase, subjects will undergo regular scheduled assessments. Response evaluations will be continued every 4 cycles from the initial dose with study drug until 36 months and then every 6 cycles until disease progression.
All subjects will undergo an End-of-Treatment visit up to 30 days after discontinuation of randomized treatment and will then be followed for survival and subsequent anti-cancer therapies.
Ibrutinib is a "kinase inhibitor” by blocking the activity of this specific kinase, it is possible that the Ibrutinib may kill the cancer cells or stop them from growing. This is an oral tablet.
Chlorambucil is an alkylating agent. This type of drug works by killing cancer cells. This is an oral tablet.
Obinutuzumab is a monoclonal antibody. This type of drug works by attaching to cancer cells and mimicking the antibodies the body naturally produces to help fight the cancer cells. This is an IV infusion.
The following assements will be included: physcial exams, blood sampling, vital signs, Electrocardiogram (ECG), patient questionnaire, bone marrow biopsy, CT/MRI scans.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
14/YH/1175
Date of REC Opinion
10 Dec 2014
REC opinion
Further Information Favourable Opinion