Ibrutinib in Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma
Research type
Research Study
Full title
An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton’s Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma with 17p Deletion
IRAS ID
120439
Contact name
Peter Hillmen
Contact email
Sponsor organisation
Pharmacyclics, Incorporated
Eudract number
2012-004476-19
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
This is a multicentre, international, open-label, single arm, Phase 2 study designed to evaluate the efficacy and safety of PCI-32765 in subjects with relapsed/refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) with 17p deletion. The study will include approximately 111 subjects with relapsed or refractory disease who have active disease requiring treatment. The study will include a Screening Phase, a Treatment Phase, and a Follow-up Phase. The Screening Phase assessments will be performed within 28 days prior to treatment. The Treatment Phase will extend from first dose until study drug discontinuation. All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily until disease progression or unacceptable toxicity occurs. During the study, subjects will undergo efficacy assessments at Weeks 9, 17, 25, 37, 49, 61, 73, 85, and every 24 weeks thereafter until disease progression or until study closure. If PCI-32765 treatment is discontinued in the absence of progression (i.e., for adverse event or Investigator decision), these subjects will complete a 30 day End-of-Treatment Visit. After completion of PCI-32765, all subjects (except those who withdraw full consent) will undergo a 30 day End-of-Treatment Visit, followed by a long-term Follow-up Phase. During the Follow-up Phase, subjects will be followed for survival and initiation of subsequent anticancer therapy by questionnaire for a minimum of 18 months after the last subject is enrolled. The Follow-up Phase will continue until death, loss to follow up, consent withdrawal, or study end, whichever occurs first.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
13/YH/0003
Date of REC Opinion
25 Jan 2013
REC opinion
Further Information Favourable Opinion