TIDaL
Research type
Research Study
Full title
Risk-stratified sequential Treatment with Ibrutinib and Rituximab (IR) and IR-CHOP for De-novo post-transplant Lymphoproliferative disorder (PTLD)
IRAS ID
198051
Contact name
Sean Jennings
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2015-005454-35
Duration of Study in the UK
4 years, 4 months, 1 days
Research summary
After an organ or bone marrow transplant, patients with weakened immune systems can develop a condition called post-transplant lymphoproliferative disorder (PTLD). The standard treatment for PTLD in the UK is the initial use of the ‘monoclonal antibody’ drug rituximab, which is successful in treating PTLD. However, the majority of patients may not respond very well to rituximab on its own and, in these cases, chemotherapy will be added to achieve or improve a response. The standard chemotherapy treatment used in these patients is called ‘R-CHOP’. This involves having a course of rituximab (R), together with a combination of other drugs called cyclophosphamide, vincristine, doxorubicin and prednisolone (CHOP). Studies have shown that R-CHOP is effective at treating PTLD but patients are at a higher risk of infection and this treatment has a higher risk of causing damage to the transplanted organ. A drug called ibrutinib has recently been licensed for use in other haematological conditions. Studies have shown ibrutinib, and ibrutinib with rituximab, to be effective at treating other forms of lymphoma. The aim of this study is to find out if adding ibrutinib to rituximab (IR) can improve the initial response to rituximab and result in fewer patients requiring R-CHOP treatment.
This is a multicentre trial evaluating the addition of ibrutinib to rituximab (IR) in patients diagnosed with PTLD. 40 solid organ transplant patients and up to 20 stem cell transplant patients will receive IR therapy for 7 weeks, after which they will receive IR (if they have responded well to treatment) or IR-CHOP chemotherapy (if they have not responded to treatment) based on an initial CT scan response. Patients will be recruited over a 2 year period across hospitals in the UK. Patients will receive approximately 5 months of therapy. All patients will be followed up for 2 years.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0279
Date of REC Opinion
15 Sep 2016
REC opinion
Further Information Favourable Opinion