Ibrutinib in Subjects with Relapsed/Refractory Marginal Zone Lymphoma
Research type
Research Study
Full title
A Multicenter, Open-Label, Phase 2 Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects with Relapsed/Refractory Marginal Zone Lymphoma
IRAS ID
151095
Contact name
Simon Rule
Contact email
Sponsor organisation
Pharmacyclics Incorporated
Eudract number
2013-003561-34
Clinicaltrials.gov Identifier
Research summary
This is a multi-centre, open-label, Phase 2 study of the Bruton’s Tyrosine Kinase (BTK) inhibitor, ibrutinib, in subjects with relapsed/refractory Marginal Zone Lymphoma (MZL).
Lymphoma is the most common blood cancer and is sub-divided into two main forms: Hodgkin’s lymphoma and non-Hodgkin’s lymphoma. Marginal Zone Lymphoma is the third most common type of non-Hodgkin’s lymphoma. MZL occurs when cells of the immune system called lymphocytes, a type of white blood cell, grow and multiply uncontrollably. Cancerous lymphocytes can travel to many parts of the body, including the lymph nodes, spleen, bone marrow, or other organs, and form a mass called a tumour.
Marginal Zone Lymphoma is characterised by enlarged lymph nodes. Symptoms may include loss of appetite, tiredness, night sweats, unexplained high temperatures and weight loss. Almost 2000 new cases of MZL are diagnosed each year in the UK alone.
The purpose of this study is to evaluate the effectiveness of ibrutinib on difficult to treat (refractory) MZL. Furthermore, the duration of the response to ibrutinib as well as the safety profile and maximum tolerability of ibrutinib will be evaluated. It is hoped that ibrutinib may result in clinical benefit to people with MZL.
The study will be carried out at approximately 35 study sites in the United States and Europe with approximately 60 participants that will be invited to participate.
This is a single-arm, two-stage study which means 19 subjects will be included in the first stage, and an expansion to a total of 60 participants will occur if a good response is received.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
14/NE/0121
Date of REC Opinion
2 Jun 2014
REC opinion
Further Information Favourable Opinion