Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL

Exclusion Criteria

• •History of another malignancy within 2 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy
• •History of progressive multifocal leukoencephalopathy (PML)
• •Active cerebral/meningeal disease related to the underlying malignancy. Participants with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior CNS disease has been effectively treated and without progression for at least 3 months.
• •Any uncontrolled Grade 3 or higher (per NCI CTCAE version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug. Routine antimicrobial prophylaxis is permitted
• •Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 3 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment
• •Previous treatment with brentuximab vedotin or lenalidomide.
• •* Previous treatment with other vedotin-based ADCs is permitted if the last dose is at least 6 months prior to Day 1.
• •Current therapy with immunosuppressive medications (including steroids), other systemic anti-neoplastic, or investigational agents
• •a) Prednisone (or equivalent) ≤10 mg/day may be used for non-lymphomatous purposes
• •Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to the first dose of study drugs
• •Congestive heart failure, Class III or IV, by the NYHA criteria
• •Grade 2 or higher peripheral sensory or motor neuropathy at baseline