Response Adapted Incorporation of Tislelizumab Into the Front-line Treatment of Older Patients With Hodgkin lYmphoma

Exclusion Criteria

• •1. Nodular lymphocyte predominant Hodgkin lymphoma
• •2. History of autoimmune disorders (with the exception of hypothyroidism, type 1 diabetes, vitiligo, alopecia)
• •3. History of solid organ transplant
• •4. Grade 2 or higher peripheral neuropathy
• •5. Presentation with disease causing symptomatic compression of vital structures (e.g. stridor due to tracheal compression). Other cases of radiological compression of vital structures require discussion with TMG prior to registration
• •6. Women who are pregnant or breastfeeding
• •7. Active hepatitis B or C infection defined by
• •1. Hepatitis B surface antigen positivity OR
• •2. Anti-hepatitis B core antibody positivity with detectable circulating HBV DNA (hepatitis B core antibody patients with undetectable circulating HBV DNA are eligible but must take suitable prophylaxis for reactivation)
• •3. Anti-Hepatitis C antibody positivity unless patient has been treated for hepatitis C and has undetectable HCV RNA
• •8. Known HIV infection
• •9. Positive PCR for SAR-CoV-2 RNA within the 2 weeks prior to registration. Patients with a history of SARS-CoV-2 are required to have a documented negative PCR swab since documented SARS-CoV-2 infection
• •10. Immunosuppressive therapy within the 2 months prior to registration apart from inhaled, intranasal or topical corticosteroids. Systemic corticosteroids are permitted prior to study entry but must be weaned to 10 mg prednisolone / day for a minimum of 7 days prior to cycle 1 day 1
• •11. Live vaccine given within 30 days prior to registration
• •12. Active infection requiring systemic therapy with ongoing symptoms at registration or where the planned duration of therapy would continue beyond cycle 1 day 1
• •13. Major surgery within 4 weeks prior to registration (excisional biopsy is not considered major surgery)
• •14. Myocardial infarction, unstable angina, coronary artery bypass graft, cerebrovascular accident or transient ischaemic attack within 6 months prior to registration
• •15. Previously treated haematological malignancy
• •16. Solid-organ malignancy active within the last 3 years, except where the natural history or treatment does not have the potential to interfere with assessment of safety or efficacy of trial treatment, for example:
• •1. Adequately treated non-melanoma skin cancer considered to be in remission
• •2. Melanoma in situ following resection
• •3. Carcinoma in situ of the breast or cervix
• •4. Carcinoma of the prostate of Gleason grade 6 or less with stable prostate-specific antigen levels
• •5. Cancer considered cured by surgical resection or unlikely to impact survival in the next 3 years, for example local transitional carcinoma of the bladder or benign tumours of the adrenal gland or pancreas
• •17. A history of other malignancies should be discussed with the trial management group prior to registration
• •18. Patient not fit for AVD chemotherapy in the opinion of the investigator