Ibrutinib in paediatrics and young adults with non-Hodgkin Lymphoma
Research type
Research Study
Full title
A Randomized, Open-label, Safety and Efficacy Study of Ibrutinib in Paediatric and Young Adult Patients With Relapsed or Refractory Mature B-cell non-Hodgkin Lymphoma
IRAS ID
203358
Contact name
Frank de Beukelaar
Contact email
Sponsor organisation
Janssen Cilag International NV
Eudract number
2016-000259-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 5 months, 2 days
Research summary
This is a two-part, multicentre study in children and young adults with mature B-cell non-Hodgkin Lymphoma (NHL) that has returned after previous treatment. NHL is a cancer of the lymph nodes (glands) and other associated areas throughout the body.
Standard care chemoimmunotherapy (CIT) provides cure for types of NHL in approximately 85-90% of paediatric cases. For those patients whose disease returns, long-term survival is poor, with only approximately 10-20% of these patients surviving for more than 2 years. As such, there is a clear, unmet medical need for new treatment options.
Ibrutinib is a new treatment for NHL which is approved for some other cancers, but there is no clinical experience in children. Ibrutinib works by blocking the protein known as Bruton’s tyrosine kinase, which helps cancer cells to grow.
Part 1 of the study (conducted before starting Part 2) is designed to confirm the right dose for Part 2, and will enrol approximately 6 – 12 patients between 1 – 18 years. Part 2 is a randomised, open label, phase 3 study to compare the safety and efficacy of Ibrutinib in combination with standard care CIT versus standard care CIT alone. During part 2, approximately 72 patients between 1 – 30 years will be enrolled.
Part 1 and 2 of the study will be conducted in 3 phases: a pre-treatment screening phase of up to 14 days, a treatment phase of up to 12 weeks (3 cycles) and a post-treatment phase. For patients who received Ibrutinib and showed a good response, patients may receive an additional 3 cycles of Ibrutinib alone or until their disease gets worse, or they have unacceptable toxicity, or up to the start of subsequent antilymphoma therapy or stem cell transplantation, whichever comes first. Those patients who did not receive Ibrutinib, or who did not show a good response, patients will be able to start antilymphoma therapy.
At the end of the treatment phase, all patients will enter the post-treatment phase. The post-treatment phase involves follow up visits every 12 weeks for the first 12 months, and then every 6 months.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
16/EM/0240
Date of REC Opinion
8 Aug 2016
REC opinion
Further Information Favourable Opinion