IPI-145 vs Ofatumumab in CLL or SLL
Research type
Research Study
Full title
A Phase 3 Study of IPI-145 versus Ofatumumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
IRAS ID
142299
Contact name
Peter Hillmen
Contact email
Sponsor organisation
Verastem, Inc
Eudract number
2013-002405-61
Clinicaltrials.gov Identifier
112,486, IND Number:
Duration of Study in the UK
4 years, 2 months, 12 days
Research summary
This study will compare the effects, good or bad, of a drug called IPI-145 with a drug called ofatumumab in participants with chronic lymphocytic leukaemia (CLL) cancer or small lymphocytic leukaemia (SLL) cancer to find out which is better.
In this study, participants will not get both drugs.
IPI-145 is a new investigational drug designed to stop cancer growth by blocking PI3 kinase activity. PI3 kinase is an enzyme in the body that is overproduced by some cancers and can fuel cancer growth. PI3 kinase activity is known to be elevated in many blood cancers. Although the studies with IPI-145 have been limited, some patients (about 50) with CLL received IPI-145 given as monotherapy (treatment with only IPI-145 and no other anti-cancer drugs) with tolerable symptoms and a decrease in their cancer.
Ofatumumab belongs to a group of medicines called monoclonal antibodies. Ofatumumab works by binding to the lymphocytes (a variety of white blood cell) and causes the lymphocytes to die. Ofatumumab is licensed for use in the United Kingdom.
In addition to comparing both the good and bad effects of IPI-145 and ofatumumab, this study will also:
• Assess participants’ general health, well-being and overall quality of life (QOL) while they are on the study.
• Try to understand why participants’ cancer may or may not respond to study drug treatment (Biomarker Testing).
• Look at the effect an individual’s genes have on how the study drug is broken down or moved through the body (this is called pharmacogenomics and this is optional).
• Measure the amount of IPI-145 and compounds related to IPI-145 in the body at different times (this is called pharmacokinetics and will only be done if participants are taking IPI-145).REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/0002
Date of REC Opinion
17 Feb 2014
REC opinion
Further Information Favourable Opinion