Study of Safety and Efficacy of Betalutin and Rituximab in Patients With FL

Exclusion Criteria

• •Previous haematopoietic stem cell transplantation (autologous and allogenic)
• •Evidence of histological transformation from FL to DLBCL at time of screening.
• •Previous total body irradiation
• •Chemotherapy, immunotherapy or investigational therapy within 28 days before the start of study drug administration (corticosteroid treatment at doses of ≤20 mg/day, topical or inhaled corticosteroids, granulocyte colony-stimulating factor \[G-CSF\] or granulocyte-macrophage colony-stimulating factor \[GM CSF\] are permitted up to 2 weeks prior to start of study treatment) or failure to recover from AEs associated with prior treatment
• •Previous treatment with radioimmunotherapy
• •Patients who are receiving any other investigational medicinal products
• •Known or suspected central nervous system (CNS) involvement of lymphoma
• •History of a previous treated cancer except for the following:
• •1. adequately treated local basal cell or squamous cell carcinoma of the skin
• •2. cervical carcinoma in situ
• •3. superficial bladder cancer or localised prostate cancer undergoing surveillance or surgery
• •4. localised breast cancer treated with surgery and radiotherapy but not including systemic chemotherapy
• •5. other adequately treated Stage 1 or 2 cancer currently in CR
• •Pregnant or lactating women
• •Exposure to another CD37 targeting drug
• •A known hypersensitivity to RTX, lilotomab, Betalutin or murine proteins or any excipient used in RTX, lilotomab or Betalutin
• •Receipt of live, attenuated vaccine within 30 days prior to enrolment
• •Evidence of severe or uncontrolled systemic diseases (e.g. ongoing infection, respiratory, cardiac, hepatic or psychiatric conditions) which in the Investigator's opinion would compromise the protocol objectives