If you are still PET positive after 8 cycles of nivolumab, you will be asked to have an additional lymph node biopsy, but this is optional. If you have questions We hope you find this information sheet helpful. We appreciate it may not answer all of your questions, so please do not hesitate to contact us on the telephone numbers given at the end of this Patient Information Sheet if you would like to discuss any aspect of the study further. Thank you Thank you for reading his information. If you take part, you will help us to understand more about this disease and its treatment. This may help future people with Hodgkin lymphoma. Why are we doing this study? This is for patients with Hodgkin lymphoma which has either come back after (relapsed) initial successful treatment, or has not responded well enough to initial treatment. Currently, standard treatment is a combination of chemotherapy drugs (called ‘first line’ salvage treatment), followed by an assessment with a PET-CT scan. If the PET-CT scan has become negative (meaning that the disease has been effectively treated), patients are usually offered a transplant using their own stem cells straight away or after a further cycle of the same chemotherapy. Having a negative PET-CT scan before having a stem cell transplant is important because previous research has that the chance of cure after transplant is much greater if the PET-CT scan beforehand is trial
Research Ethics Committee and has also been approved by the Research and Development department at your hospital. The study has also been peer reviewed by independent lymphoma experts from across the world, the National Cancer Research Institute’s Lymphoma Clinical Trials Group and an independent statistician. Thank You Thank you for considering taking part in this study and for taking the time to read this Patient Information Sheet, which is yours to keep. If you decide to take part in the study, you will also be given a copy of your signed consent form. Further Information You may wish to contact one of the following organisations that are independent of the hospital at which you are being treated: Macmillan Cancer Support provides practical, medical and financial support and work towards the improving cancer care. They can be contacted at: Tel: 0808 808 00 00 (Freephone) Or their website at: CancerHelp (Cancer Research UK), who provide all aspects of information for people with cancer. Their contact details are: Tel: 0808 800 4040 (Freephone) Or visit their website at: The Lymphoma Association – a charity organisation providing information and support to people affected by all of lymphoma. Their contact details are: Tel: 0808 808 5555 (Freephone) Or visit their website at: Bloodwise – a charity providing support and information about all kinds of blood cancers, including lymphoma. Their website address is: If you decide you like to take part then please read and sign the consent form. You will be given a copy of this information sheet and signed consent form to keep. You can have more time to think this over if you are unsure or have more questions.
Very common (may affect more than 1 in 10 people or >10%) Diarrhoea (watery, loose or soft stools) Fatigue Itching Rash Common (may affect between 1 in 100 to 1 in 10 people or 1-10%) Abdominal pain Alkaline phosphatase increased (lab test result associated with liver or bone abnormalities) ALT increased (lab test associated with abnormal liver function) Amylase increased (lab test result associated with pancreas inflammation) AST increased (lab test associated with abnormal liver function) Chills Constipation Cough Creatinine increased (lab test result associated with decreased kidney function) Decreased appetite Dizziness Dry mouth Dry skin Fever Headache Increased blood sugar Inflammation of the colon Inflammation of the Infusion related reaction Joint pain or stiffness Lipase increased (lab test result associated with pancreas inflammation) Loss of colour (pigment) from areas of the skin Lung inflammation (pneumonitis) Musculoskeletal pain Nausea Redness Shortness of breath Low sodium levels in the blood Swelling, including face, arms and legs Thyroid function decreased Thyroid function increased Thyroid stimulating hormone increased (lab test result associated with abnormal thyroid function) Vomiting Uncommon (may affect between 1 in 1,000 to 1 in 100 people or 0.1-1%) Adrenal gland function decreased Allergic reaction/hypersensitivity Bilirubin increased (liver function blood test) Bronchitis Cranial disorder Diabetes Dry eyes Hair loss Heart rate increased rhythm abnormal High blood pressure Hives Inflammation of the eye Inflammation of the kidney Inflammation of the pancreas Inflammation of the pituitary gland Inflammation of the stomach Inflammation of the thyroid gland Liver inflammation Low blood pressure Lung infiltrates, associated with infection or inflammation Pituitary function increased Psoriasis: characterised by patches of abnormal, scaly skin (kidney) failure or kidney injury Respiratory failure Upper respiratory tract infection Vertigo (feeling off balance which can lead to dizziness) Vision blurred Rare (may affect between 1 in 10,000 to 1 in 1000 people or 0.01%-0.1%) Anaphylactic reaction (severe allergic reaction) Damage to the protective covering of the nerves in the and spinal cord Diabetes complications resulting in excess blood acids an diabetic coma
Before cycle 7 Clinical examination Blood counts Blood chemistry Pregnancy test (women of childbearing potential only) Thyroid function (additional tests done on the blood samples you have as standard) Oxygen saturation Tests for autoimmune conditions Before cycle 8 Clinical examination Blood counts chemistry Blood sample (20ml) to be sent to central laboratory Oxygen saturation Tests for autoimmune conditions (additional tests done on the blood samples you have as standard) End of cycle 8 None PET-CT scan Contrast enhanced CT scan Lung function test Repeat tumour biopsy to be sent to central laboratory (optional; if PET positive) 1 month after treatment Clinical examination Blood counts Blood chemistry sample (20ml) to be sent to central laboratory Tests for autoimmune conditions (additional tests done on the blood samples you have as standard) Thyroid function tests (additional tests done on the blood samples you have as standard) Pregnancy test (women of childbearing potential only) 2 months treatment Clinical examination Blood counts chemistry Tests for autoimmune conditions (additional tests done on the blood samples you have as standard) Thyroid function (additional tests done on the blood samples you have as standard) Pregnancy test (women of childbearing potential only) 3 months after treatment Clinical examination counts Blood chemistry for autoimmune conditions (additional tests done on the blood samples you have as standard) Thyroid function tests (additional tests done on the blood samples you have as standard) Pregnancy test (women of childbearing potential only) 1 year after treatment Clinical examination Blood counts Blood chemistry Lung function test