Venetoclax and Obinutuzumab for Relapsed/Refractory Primary CNS Lymphoma

Exclusion Criteria

• •1. Known allergy to venetoclax or other components of the formulation
• •2. Known allergy to obinutuzumab or other components of the formulation
• •3. Primary ocular lymphomas without brain parenchymal involvement
• •4. Lymphoma relapse outside the CNS; extra CNS relapse needs to be ruled out by body CT scans (neck till pelvis) or PET-CT scans.
• •5. Contraindications for lumbar puncture at the discretion of the clinical investigator
• •6. Prior exposure to obinutuzumab or venetoclax
• •7. Other additional anti-lymphoma treatment, e.g. chemotherapy or radiotherapy
• •8. Active hepatitis B or C
• •9. HIV seropositivity
• •10. Chronic use of immunosuppressive drugs, e.g. steroids for systemic autoimmune disease
• •11. Active infections requiring treatment
• •12. Other active malignancies (except non-melanoma skin cancer). Prior malignancies without evidence of disease for at least 5 years are allowed
• •13. Patient is pregnant or breastfeeding, or expecting to conceive or father children within one year of finishing venetoclax and 18 months for obinutuzumab.
• •14. Prior allogeneic haematopoietic stem cell or solid organ transplantation
• •15. Therapeutic intervention in setting of other former interventional clinical trial within 30 days before the first IMP administration in VENOBI study; simultaneous participation in registry and diagnostic studies or follow up of an interventional trial is allowed
• •16. Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial
• •17. Known or persistent abuse of medication, drugs or alcohol
• •18. Person who is in a relationship of dependence/employment with the sponsor or the investigator
• •19. Administration of moderate or strong CYP3A inhibitors or inducers within 1 week of initiation of venetoclax dosing.