Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND)

Exclusion Criteria

• •Any other histological type of lymphoma according to the WHO 2016 classification of lymphoid neoplasms, including:
• •1. primary mediastinal (thymic) large B-cell lymphoma,
• •2. Burkitt lymphoma,
• •3. Primary refractory diffuse large B-cell lymphoma (DLBCL),
• •4. History of double- or triple-hit DLBCL.
• •Participants who, within 30 days prior to Cycle 1 Day 1, have:
• •1. Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma-specific therapy
• •2. Undergone major surgery or suffered from significant traumatic injury
• •3. Received live vaccines or have an anticipated need for such vaccination while receiving study treatment
• •4. Required parenteral antimicrobial therapy for active, intercurrent infections
• •Have undergone ASCT within the period ≤ 3 months prior to signing consent.
• •Have undergone previous allogenic stem cell transplantation.
• •Inadequate recovery (\> Grade 1) from prior treatment toxicity and/or complications from major surgery before Cycle 1 Day 1.
• •Have a history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or are at high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period.
• •Prior history of malignancies other than DLBCL, unless disease-free for ≥ 5 years prior to screening.
• •Clinically significant cardiac disease, including unstable angina, acute myocardial infarction, New York Heart Association Class II to IV congestive heart failure, uncontrolled arrhythmia, and/or cardiac conduction issues, within 6 months of Cycle 1 Day 1.
• •Any of the following positive tests:
• •1. Known seropositive for or history of active viral infection with HIV.
• •2. Known positive test result for hepatitis C (HCV antibody serology testing) and a positive test result for HCV RNA.
• •3. Known positive test results for chronic HBV infection (defined by HBsAg positivity). Participants with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA was undetectable