Assessment of the Tolerability and Optimal Dosing of the Combination of Brentuximab Vedotin and Lenalidomide in Patients With Relapsed or Refractory T‐cell Lymphoma: Results of a Single‐centre Phase 1 Dose‐escalation Study

ABSTRACT Objective We report the results of a pilot study investigating the combination of brentuximab vedotin (BV) and lenalidomide in patients with relapsed/ refractory T‐cell lymphoma. Methods A dose escalation study design was utilized. Primary and secondary endpoints included maximum tolerated dose (MTD), adverse events, and response rates. Results Six patients were treated with BV and two dose levels of lenalidomide, in 21‐day cycles. The protocol‐determined MTD was BV 1.8 mg/kg and lenalidomide 25 mg, however, all patients required subsequent dose reductions with ongoing treatment. The most common adverse event was peripheral neuropathy in four of six patients. Two patients achieved complete responses and three achieved partial responses. Discussion: The combination is deliverable with dose attenuation. Further study is needed to define clinical benefit. Clinical Trial Registration This trial was registered on ClinicalTrials.gov (NCT number 03302728).