Bruton’s Tyrosine Kinase Inhibitor, Treatment for Follicular Lymphoma
Research type
Research Study
Full title
A Multicenter, Randomized, Double-blind, Placebo-controlled\nPhase 3 Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor,\nIbrutinib, in Combination with Rituximab versus Placebo in\nCombination with Rituximab in Treatment Naïve Subjects with\nFollicular Lymphoma
IRAS ID
219530
Contact name
Simon Rule
Contact email
Sponsor organisation
Pharmacyclics LLC
Eudract number
2016-003202-14
Duration of Study in the UK
8 years, 0 months, 0 days
Research summary
The present study is a phase 3, Multicentre, Randomised, Double-blind, Placebo-controlled study of Bruton’s Tyrosine Kinase Inhibitor, Ibrutinib, in Combination with Rituximab versus Placebo in Combination with Rituximab in Treatment Naïve Patients with Follicular Lymphoma.\nThe purpose of this research study is to establish the safety profile of the medication in patients with follicular lymphoma who have never been treated for this cancer.\nIbrutinib is a “kinase inhibitor”. “Kinases” are proteins inside cells that help cells live and grow. The specific kinase inhibited or “blocked” by ibrutinib is believed to help blood cancer cells live and grow. By inhibiting the activity of this specific kinase, it is possible that the ibrutinib may kill the cancer cells or stop them from growing. Rituximab is a “monoclonal antibody”. It is believed that rituximab works by using the body’s immune system to attack the cancer. Rituximab may work by attaching to cancer cells (lymphocytes) and causing the cells to die or by signalling the immune system to destroy the cancer cells.\nParticipants will be randomly assigned to a treatment arm, with a 75% chance of being assigned to treatment Arm A, who will receive four ibrutinib oral capsules and a 25% chance of being assigned to treatment Arm B, who will receive placebo capsules. Neither participant nor the Study Staff will know if they are taking ibrutinib or the placebo that contains no medication.\nUp to 440 participants will participate in the study. This study will take place at approximately 200 centres worldwide.\nParticipation is expected to last approximately 8 years and will include going to the study centre at different time points based on how long participants are on the study.\n
REC name
South West - Central Bristol Research Ethics Committee
REC reference
17/SW/0011
Date of REC Opinion
12 Apr 2017
REC opinion
Further Information Favourable Opinion