We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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.
Mrs
Amber
Cole
+44 (0)23 8120 5154
PRICEtrial@soton.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Relapsed/refractory diffuse large B-cell 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.
Lymphoma is cancer that begins in the infection-fighting cells of the immune system, called lymphocytes. More than 13,000 new cases of non-Hodgkin's lymphoma are diagnosed in the UK each year. Diffuse large B cell lymphoma (DLBCL) is the most common, accounting for around 5,000 new cases per year. Rituximab with CHOP chemotherapy is the standard first-line treatment but in a third of patients, it does not work. The majority of these patients will die from their disease, as the success of salvage treatments is limited after treatment with rituximab. Patients who have few other complications are able to have high-dose therapy (stem cell transplant) after second-line (+) treatment but only if they are in complete remission. There is a growing need to find better second-line treatments that allow patients eligible for high dose therapy to receive it.
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. Previous lymphoma cancer treatment beyond third line2. Radiotherapy or cytotoxic drugs within two weeks of trial treatment3. Major surgery within 4 weeks of trial registration. If a subject had major surgery,more than 4 weeks ago, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug4. Treatment with any unlicensed drug within 4 weeks of trial treatment5. History of stroke or intracranial haemorrhage within 6 months prior to registration6. Pre-existing peripheral neuropathy grade >27. Clinically significant cardiac disease (inc. unstable angina,acute myocardial infarction,congestive heart failure,a current LVEF of <40%) within 6 months of registration8. Any significant uncontrolled medical condition or known hypersensitivity to the study drugs9. Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as,but not limited to, chronic renal infection, chronic chest infection with bronchiectasis and tuberculosis10. Other past or current malignancy within 2 years prior to registration unless in the opinion of the investigator it does not contraindicate participation in the study. Subjects who have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma, are eligible11. Known CNS involvement12. Serological positivity for Hepatitis B, C, or known HIV infection. As per standard of care,prior to initiation of immunochemotherapy, the results of hepatitis serology should be known prior to commencement of therapy. 13. Positive test results for chronic HBV infection (defined as positive HBsAg serology) will not be eligible14. Patients with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) will not be eligible15. Patients who have protective titres of hepatitis B surface antibody (HBsAb) after vaccination will be eligible16. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA17. Screening laboratory values :17.1. platelets <75 x 10e9/L (unless due to lymphoma involvement of the bone marrow)17.2. neutrophils <1.0 x 10e9/L (unless due to lymphoma involvement of the bone marrow)17.3. creatinine >2.0 times upper normal limit (unless due to lymphoma or unless creatinine clearance >50 ml/min)17.4. total bilirubin >1.5 times upper normal limit (unless due to lymphoma or a known history of Gilbert’s disease)17.5. ALT/AST >2.5 times upper normal limit (unless due to lymphoma)17.6. Alkaline phosphatase >2.5 times upper normal limit (unless due to lymphoma)18. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. (Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone will be eligible as will be patients with controlled Type I diabetes mellitus on a stable dose of insulin).19. Patients who have previously undergone allogeneic transplantation20. Live vaccination within 28 days of study treatment21. Pregnant or lactating females. Women of child-bearing potential should have negative pregnancy test22. History of severe allergic anaphylactic reactions to chimeric,human or humanised antibodies,or fusion proteins23. History of (non-infectious) pneumonitis that required steroids or has current pneumonitis24. Known hypersensitivity to CHO cell products or any component of the pembrolizumab formulation25. Previous treatment with an anti-PD-1,anti-PD-L1 or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)26. Corticosteroid use >10 mg/day of prednisolone or equivalent,for purposes other than for lymphoma symptom control. Patients receiving corticosteroid treatment with <10 mg/day of prednisolone or equivalent must be documented to be on a stable dose of at least 4 weeks’ duration prior to the start of Cycle 1. If glucocorticoid treatment is urgently required for lymphoma symptom control prior to the start of study treatment, prednisolone 100 mg or equivalent could be given for a maximum of 14 days as a pre-phase. A dose of up to 10 mg or prednisolone or equivalent may be used during the screening phase to control symptoms.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mrs
Amber
Cole
+44 (0)23 8120 5154
PRICEtrial@soton.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University Hospital Southampton NHS Foundation Trust and funded by Merck; Grant Codes: 56804.
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 51402
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
