Phase Ib Study to Assess Safety and Preliminary Efficacy of Tafasitamab or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed DLBCL

Inclusion Criteria

• Age >18 years
• Histologically confirmed diagnosis of DLBCL, not otherwise specified (NOS)
• Tumor tissue for retrospective central pathology review and correlative studies must be provided.
• At least one bidimensionally measurable, PET positive disease site (greatest transverse diameter of ≥1.5 cm, greatest perpendicular diameter of ≥1.0 cm)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• International Prognostic Index (IPI) status of 2 to 5
• Appropriate candidate for R-CHOP
• Left ventricular ejection fraction (LVEF) of ≥50% assessed by echocardiography or cardiac multi-gated acquisition (MUGA) scan
• Adequate hematologic, liver and renal function
• Females of childbearing potential (FCBP) must:
• not be pregnant
• refrain from breast feeding and donating oocyte
• agree to ongoing pregnancy testing
• commit to continued abstinence from heterosexual intercourse, or agree to use and be able to comply with the use of double-barrier contraception
• Males must:
• use an effective barrier method of contraception if sexually active with FCBP
• refrain from donating sperm
• In the opinion of investigator, the patient must be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events Major

Exclusion Criteria

• Any other histological type of lymphoma according to World Health Organization (WHO) 2016 classification of lymphoid neoplasms, known double- or triple-hit lymphoma
• Transformed non-Hodgkin lymphoma (NHL) and/or evidence of composite lymphoma
• History of radiation therapy to ≥25% of the bone marrow or history of anthracycline therapy
• History of prior non-hematologic malignancy except for the following:
• Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening
• Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer
• Adequately treated carcinoma in situ without current evidence of disease
• History of myocardial infarction ≤6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening arrhythmias
• Patients with:
• positive test results for active hepatitis B and C
• known seropositive for or history of active viral infection with human immunodeficiency virus (HIV)
• known active bacterial, viral, fungal, mycobacterial, or other infection at screening
• known central nervous system (CNS) lymphoma involvement
• history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator opinion preclude participation in the study