HOVON 168:Study on epcoritamab in frail patients with diffuse large B-Cell lymphoma (DLBCL) who have not been treated before

Prior treatment

• Patient has history of prior systemic anti-lymphoma therapy for DLBCL
• Subject with histologically transformed FL, who has previously been treated with > 1 lines of therapy for FL
• Patient has medication known to decrease T-cell numbers or activity or other concurrent immunosuppressive medication or has received any live vaccine within 28 days prior to the first dose of study drug or is expected to need any live vaccination during study treatment.
• Patient has been treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study treatment or is currently taking an investigational drug or is participating in another interventional study until participant is in the survival follow-up phase.
• Male patient who is considering fathering a child or donating sperm during the study or for 12 months after the last dose of study drug.

Other illness

• Patient has history of primary mediastinal lymphoma, or mediastinal or pericardial radiation
• Patient has life-threatening illness, medical condition, or organ system dysfunction that, in the Investigator's opinion, could compromise the patient's safety, compliance with the protocol, interpretation of the study results, or put the study outcomes at undue risk.

Lab values

• Patient has: history of severe allergic or anaphylactic reactions to anti-CD20 mAb therapy or known allergy or intolerance to any component or excipient of epcoritamab or CHOP; known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection; active hepatitis B virus or Hepatitis C virus or HIV infection; active tuberculosis or history of completed treatment for active TB within the past 12 months; active (symptomatic) CMV disease; known active SARS-CoV-2 infection; major surgery within 4 weeks prior to randomization; clinically significant cardiovascular disease; LVEF <45%; clinically significant liver disease; history of Progressive Multifocal Leukoencephalopathy; history of other prior malignancies; neuropathy Grade > 1; current seizure disorder requiring therapy within the past 12 months.

Other

• Patient has a primary CNS tumor or known CNS involvement

• Patients must voluntarily sign and date an informed consent
• Patient has measurable disease
• Adult individuals, at least 70 years old with a life expectancy of ≥ 12 months
• Laboratory values meeting the protocol defined criteria within the screening period prior to the first dose of study drug
• Are willing and able to comply with procedures required in this protocol.
• Are able to tolerate SC injections.
• Have available adequate fresh or paraffin-embedded tumor biopsy material at Screening.
  • 7 Newly diagnosed, histologically confirmed CD20+ DLBCL NOS, CD20+ Follicular large B-cell lymphoma transformed follicular lymphoma, or CD20+ DLBCL/high grade B-cell lymphoma (HGBL) with MYC and BCL2 rearrangements.
• ECOG performance status score of 0-2 (3 may be allowed if Grade 3 status is related to lymphoma)
• Ann Arbor Stage I(E) bulky disease (>10 cm), stage II – IV