Extension study of IPI-145 and Ofatumumab in Patients with CLL/SLL
Research type
Research Study
Full title
A Study of IPI-145 and Ofatumumab in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Previously Enrolled in Study IPI 145-07
IRAS ID
140743
Contact name
Peter Hillmen
Contact email
Sponsor organisation
Infinity Pharmaceuticals, Inc.
Eudract number
2013-003639-31
Research summary
Study IPI-145-12 is an extension study of IPI-145-07 where participants were treated with either IPI-145 or Ofatumumab for chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) (types of blood cancers).
This study is designed to enable participants whose disease got worse in Study IPI-145-07 to receive the opposite treatment (either IPI-145 or ofatumumab) than what they received during the study IPI-145-07.
The study plans to:
• Look at how IPI-145 alone helps in treating participants with CLL/SLL after they are treated with ofatumumab in the IPI-145-07 study
• Look at how ofatumumab alone helps in treating participants with CLL/SLL after they are treated with IPI-145 in the IPI-145-07 study
•Find out the side effects of IPI-145 in participants previously treated with ofatumumab
About 150 participants, males and females, 18 years of age or older, whose disease got worse on the IPI-145-07 study and meet the requirements of this study (inclusion and exclusion criteria) will be allowed in the study and the study will take part at some of the same study sites in North America, Europe and other countries that participated in the IPI-145-07 study.
The total time participants will be recruited in this study is expected to be about 2 years.
For participants receiving IPI-145, the maximum number of months they will be allowed to take the study drug is about 12 months (12 Cycles). If the treatment is having a positive effect on the cancer and they continue to tolerate treatment, they may receive IPI-145 for up to 2 years (24 Cycles).For participants receiving ofatumumab, the maximum number of months they will be receiving ofatumumab is about 7 months (7 Cycles) and then they will be followed for up to 2 years on this study.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/0003
Date of REC Opinion
17 Feb 2014
REC opinion
Further Information Favourable Opinion