ENRICH Ibrutinib for untreated mantle cell lymphoma
Research type
Research Study
Full title
Randomised, open label study of rituximab/ibrutinib vs rituximab/chemotherapy in older patients with untreated mantle cell lymphoma
IRAS ID
180518
Contact name
David Lewis
Contact email
Sponsor organisation
University Hospitals Plymouth NHS Trust
Eudract number
2015-000832-13
ISRCTN Number
ISRCTN11038174
Duration of Study in the UK
8 years, 6 months, 9 days
Research summary
Mantle cell lymphoma is a rare but aggressive form of non hodgkins' lymphoma that typically affects older patients. For younger, fitter patients the most effective treatment is considered to be stem cell transplantation. For older patients, this is not an option and they are generally offered a combination of chemotherapy and rituximab.
The purpose of this study is to compare the effect on progression-free survival of treatment with ibrutinib given in combination with rituximab (IR) against treatment with standard chemotherapy given in combination with rituximab. Participants will receive treatment for 24 weeks, followed by a 2 year maintenance period. They will then be followed up until disease progression or the end of the study, whichever comes first. We are also interested in the cost of delivering these two types of treatments, the quality of life they give patients and the side effects they cause.
This is a multicentre, open label, integrated phase II/III randomised controlled study in untreated patients with mantle cell lymphoma who are over the age of 60 and are therefore considered unsuitable for stem cell transplant. There will be an interim analysis after 77 evaluable participants have completed 24 weeks of treatment with IR in order to establish that the overall response rate with IR is high enough to justify continuing to a phase III study.
We will recruit 400 patients from as many hospitals and cancer centres in the United Kingdom as have the capacity to open the study.
ENRICH is funded by Cancer Research UK and the ibrutinib is supplied and distributed free of charge by Janssen. Janssen have also provided funds for a sub study to explore the value of minimal residual disease flow cytometry in mantle cell lymphoma.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0268
Date of REC Opinion
30 Sep 2015
REC opinion
Further Information Favourable Opinion