Open label extension study of PCI-32765 in CLL/SLL
Research type
Research Study
Full title
An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (PCI-32765 versus Chlorambucil)
IRAS ID
121275
Contact name
Talha Munir
Contact email
Sponsor organisation
Pharmacyclics, Incorporated
Eudract number
2012-003968-44
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 9 months, 1 days
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 an extension study to a parent study testing a new medicine called PCI-32765 in patients aged 65 years or older. It is hoped PCI-32765 will be a safe and effective treatment for older patients. So far PCI-32765 has only been given people in other clinical trials; it has been considered safe and well tolerated.
A patient will be transferred into this study when their disease progresses (PD= cancer gets worse) in the parent study or at closure of the parent study by the sponsor, whichever comes first. Patients receiving PCI-32765 in the parent study without PD at the time of parent study closure will continue on PCI-32765 in this extension study until PD, unacceptable toxicity or any other reason for treatment discontinuation.
The frequency of study visits, assessments and the treatment given in this study will vary depending on the treatment received in the parent study (PCI-32765 or chlorambucil), their disease-progression status and the planned treatment in the extension study. After PD, some patients may be offered second line PCI-32765 or an alternative anticancer treatment including chorambucil at the discretion of the study doctor. Patients may also elect to receive no further anticancer treatment.
Patients will be also be followed for long-term outcomes, including progression-free and overall survival, and when applicable, response to alternative treatment.Study procedures will include blood tests, physical examinations, questionnaires and CT or MRI scans; at most these scans will be performed every 4 months until month 25, then 6 monthly thereafter.
This worldwide study, sponsored by Pharmacyclics, is expected to continue for 5 years after the start of the parent study.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
13/YH/0012
Date of REC Opinion
21 Mar 2013
REC opinion
Further Information Favourable Opinion