IPI-145 with rituxumab or obinutuzumab in subjects with untreated FL
Research type
Research Study
Full title
A Two-arm, Phase 1b/2 Study of IPI-145 Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma
IRAS ID
176927
Contact name
Kirit Maganlal Ardeshna
Contact email
Sponsor organisation
Infinity Pharmaceuticals, Inc
Eudract number
2014-005459-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 20 days
Research summary
Non-Hodgkin Lymphoma, a cancer of the lymphatic system is the sixth commonest cancer in the UK. Low-grade lymphomas represent 40% of all sub-types of NHL, of which follicular lymphoma (FL) is the most frequent.
This study is to evaluate the safety and efficacy of an experimental medication, duvelisib, in the treatment of previously untreated FL. FL develops slowly and some do not undergo treatment until symptoms develop. With treatment the average survival time is 7 - 10 years. FL is considered incurable. Standard therapy is with chemotherapy and rituximab (a monoclonal antibody against CD20).This is called chemoimmunotherapy. The addition of rituximab to chemotherapy significantly improves survival. Chemotherapy has well known short and long term toxicities. Almost all patients relapse and further treatments with chemotherapy result in increased toxicity and diminished response rates and duration of response. Therefore, early treatment to augment the response and duration of response with targeted therapies which potentially have reduced toxicity compared to chemotherapy could be of significant benefit.
This clinical study was designed to test the safety and efficacy of duvelisib in combination with rituximab or an alternative anti CD20 antibody (obinutuzumab) in adults. The study will be conducted in the US and Europe at up to approximately 50 sites. The study may enroll about 120 patients over approximately 24 months. Subjects may receive treatment for up to approximately 2 years and will be followed for 3 years from receiving the first dose of study treatment or until study treatment is completed, whichever is later.The study will be conducted in 2 parts. The first part is a safety lead-in in which the study treatment will be administered in combination with either rituximab (arm 1) or obinutuzumab (arm 2). Once the safety in Part 1 has been evaluated additional subjects may be enrolled into Part 2 to assess in each treatment combination.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
15/LO/1153
Date of REC Opinion
12 Sep 2015
REC opinion
Further Information Favourable Opinion