Idelalisib in Combination with Rituximab for Previously Treated iNHL
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS 1101) in Combination with Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
IRAS ID
119932
Contact name
Peter Hoskin
Contact email
Sponsor organisation
Gilead Sciences Inc
Eudract number
2012-004013-13
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 101254
Duration of Study in the UK
6 years, 7 months, 29 days
Research summary
The present study is a multicentre, multinational, randomised, double-blind, study to evaluate an investigational medication, called idelalisib, in combination with a standard medication, called rituximab, as a possible treatment for patients with indolent non-Hodgkin lymphomas (iNHL).
In Europe, the annual incidence has been estimated at 74,000 new cases, leading to 31,000 deaths. The incidence of iNHL has increased. Diagnosis most commonly occurs in patients between 50 and 70 years of age. Existing systemic therapies for iNHL are not curative. There is an ongoing need for new and improved treatment options for patients.
All cells in the body receive signals to grow and survive, but sometimes these signals get out of control causing too much cell growth. When the growth of certain types of white blood cells gets out of control, cancers like iNHL can develop. Medicines like rituximab can kill some of the iNHL cells and can help control the disease. Medicines like idelalisib block some of the cell functions that cause iNHL to grow and survive and may also help control the disease. It is possible that giving rituximab together with idelalisib may have more activity against the iNHL disease process than giving rituximab alone. The purpose of this study is to provide more information about whether giving rituximab and idelalisib together is effective and safe for treating people with iNHL, particularly in patients who have medical problems that might make it difficult for them to receive chemotherapy for iNHL. Participants will need to be at least 18 years old and must have iNHL that has already been treated.
The study will be performed at about 100 clinics world-wide. Because it is unknown if using idelalisib and rituximab together is better than using only rituximab, the study will compare these treatments. About 375 patients will be divided into 2 groups. In one group (Group A), about 250 patients will receive idelalisib and rituximab. In the other group (Group B) about 125 patients will receive placebo with rituximab.REC name
London - Brent Research Ethics Committee
REC reference
13/LO/0855
Date of REC Opinion
9 Aug 2013
REC opinion
Further Information Favourable Opinion