1325 - Expanded access study with Idelalisib in patients with CLL
Research type
Research Study
Full title
An Expanded Access Protocol for Idelalisib in Combination with Rituximab for Relapsed, Previously Treated Subjects with Chronic Lymphocytic Leukemia
IRAS ID
149887
Contact name
Donald MacDonald
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2013-005343-82
Duration of Study in the UK
2 years, 0 months, 30 days
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. Rituximab is usually well tolerated (side effects tend to be mild), but the companion chemotherapy is often too toxic or less effective for older patients or those with coexisting medical conditions. This study is being done to test a new medicine called idelalisib or GS-1101, which is hoped to be an effective, well tolerated option for patients who have limited treatment options. So far idelalisib has only been given to patients or healthy individuals in other clinical trials, it has been considered safe and well tolerated.
This is an open-label expanded access study of Idelalisib in combination with Rituximab for relapsed, previously treated participants with CLL who have limited treatment options. The purpose of this study is to provide the Idelalisib in an open label format prior to the expected time of regulatory approval.
Participants will receive treatment until progressive disease or intolerable toxicity, study discontinuation or death (length of time in the study is expected to be on average 12 to 18 months). Participants will receive IDELA 150mg twice daily, continuously, and will also be administered 8 infusions of rituximab (every 2 weeks for 5 infusions and every 4 weeks for a further 3 infusions).
Participants will attend study visits every 2 weeks until week 8, every 4 weeks until week 24 and every 12 weeks thereafter. Participants will undergo disease assessments and receive medical care per standard of care at the site.This study is sponsored by Gilead Sciences Inc. Approximately 150 patients from approximately 50 sites in the USA and Europe will be recruited into this study, and approximately 30 patients will be recruited in the UK.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/0123
Date of REC Opinion
23 Jun 2014
REC opinion
Further Information Favourable Opinion