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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Emma
Homer
+44 (0)121 371 7861
PRiZM+@trials.bham.ac.uk
Prof
Chris
Fox
-
Christopher.Fox2@nuh.nhs.uk
Relapsed and refractory primary CNS lymphoma
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Background and study aims
Primary central nervous system lymphoma (PCNSL) is a rare type of brain tumour. It is an aggressive type of non-Hodgkin lymphoma that is found only in the brain or spinal cord. PCNSL is often treated with high doses of chemotherapy. The first treatment doesn’t work for some patients (called ‘refractory’), and the lymphoma can come back (called ‘relapse’). Refractory or relapsed (RR) PCNSL is much more difficult to treat. There is currently no standard treatment for RR-PCNSL and further chemotherapy treatment is often unsuccessful. Radiation treatment to the brain can sometimes be used but can cause significant long-term side effects.
Clinical trials are now focused on testing new drugs that are better at targeting the tumour and are likely to have fewer side effects. The treatment being tested in this study is a drug called zanubrutinib. Zanubrutinib is a new type of drug (a Bruton’s tyrosine kinase inhibitor), which works by targeting lymphoma cells. Previous studies have shown that similar drugs can cause RR-PCNSL to shrink or disappear. It is thought that zanubrutinib could be a more effective treatment that can be given safely without too many side effects. The aim of the study is to find out how effective and safe zanubrutinib is for patients with RR-PCNSL. The researchers will be looking at the effects zanubrutinib has against lymphoma, how long these effects last, and what the side effects of the drug are.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Current evidence or prior history of systemic lymphoma 2. Exclusive intraocular involvement 3. Active infection requiring intravenous antimicrobials4. Chemotherapy for lymphoma within 2 weeks of the first dose of zanubrutinib5. Whole-brain radiotherapy within 4 weeks of the first dose of zanubrutinib6. Contra-indication to lumbar puncture 7. Prior exposure to BTK inhibitor8. Known bleeding disorder e.g haemophilia or severe Von-Willebrand Disease9. Current use of warfarin, or dual anti-platelet therapy. Therapeutic anticoagulation with direct oral anticoagulants or low molecular weight heparin is permitted10. Evidence of active HIV, HBV or HCV infection, except:10.1. HIV-positive patients established on anti-retroviral treatment, with undetectable HIV RNA, after discussion with the patient’s HIV physician10.2. HBV core antibody-positive patients who are (i) surface antigen-negative and (ii) HBV DNA PCR negative, who take prophylaxis as per institutional guidelines11. Patients who are pregnant or breastfeeding (women of childbearing potential must have a negative urine or serum pregnancy test prior to trial entry)12. Patients and patients with partners of childbearing potential (pre-menopausal female capable of becoming pregnant) not willing to use highly effective contraception (see Section 9.6) during and for 12 months after cessation of therapy13. Clinically significant cardiac or respiratory dysfunction that, in the opinion of the investigator, would jeopardise the safety of the patient in the trial14. Active malignancy treated in the last 2 years, except:14.1. Non-melanoma skin cancer14.2. Carcinoma in situ of the cervix or breast14.3. Incidental finding of prostate cancer (T1a or T1b)
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.
Dr
Emma
Homer
+44 (0)121 371 7861
PRiZM+@trials.bham.ac.uk
Prof
Chris
Fox
-
Christopher.Fox2@nuh.nhs.uk
The study is sponsored by University of Birmingham and funded by Cure Leukaemia; BeiGene.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 50538
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
