IPI-145 with Rituximab vs Rituximab in Follicular Lymphoma
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of IPI-145 in Combination with Rituximab vs Rituximab in Subjects with Previously-Treated Follicular Lymphoma
IRAS ID
156701
Contact name
John Gribben
Contact email
Sponsor organisation
Infinity Pharmaceuticals Inc.
Eudract number
2013-002406-31
Clinicaltrials.gov Identifier
112,486, IND
Duration of Study in the UK
9 years, 0 months, 12 days
Research summary
This study will evaluate the effectiveness of taking IPI-145 in combination with rituximab versus taking rituximab alone to treat Follicular Lymphoma (FL).
IPI-145 is an investigational drug designed to stop cancer growth by blocking PI3 kinase activity. PI3 kinase is an enzyme in the body that certain cancers make too much and it helps them grow. PI3 kinase activity is known to be increased in many blood cancers.
Research data suggests that IPI-145 may be useful in treating blood cancers. Although the studies with IPI-145 have been limited, some patients (at least 10) with FL received IPI-145 given by itself with no other anti-cancer drugs with tolerable symptoms and some saw a decrease in their cancer.
Rituximab binds tightly to a protein called CD20, which is found on the surface B lymphocytes, a type of white blood cell. CD20 is also found on the cancerous cells in FL, so treatment with rituximab can help treat FL by reducing the number of abnormal cells. Rituximab is commonly used alone, or in combination with chemotherapy, for the treatment of FL.
Participants will be randomised to receive either IPI-145 + rituximab, or the placebo (inactive drug)+ rituximab (there will 50% chance of receiving the investigational drug).
In addition to comparing how well IPI-145 works with rituximab vs. rituximab and placebo, this study will also look at:
-Quality of life (QOL) of participants during the study
-Safety of IPI-145 in combination with rituximab
-The effect genetic information such as DNA has on how the study drug is broken down
-Measure the amount of IPI-145 in the body at different times
-Understand how cells and proteins in blood relate to potential side effects of study drug
-Understand how cancer cells or blood proteins change in response to study drug and to determine why cancer may or may not respond to study drug
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
14/NE/1215
Date of REC Opinion
7 Jan 2015
REC opinion
Further Information Favourable Opinion