drugset / Trial / NCT03302728

Brentuximab Vedotin and Lenalidomide in Patients With Relapsed/ Refractory T-cell Lymphoma or Hodgkin Lymphoma

NCT03302728

Phase 1 Completed 6 enrolled Peter MacCallum Cancer Centre, Australia
NaSingle-groupOpen-labelTreatment

Summary

This study is investigating the combination of Brentuximab vedotin and lenalidomide in the treatment of relapsed/refractory peripheral T cell lymphoma or cutaneous T cell lymphoma or Hodgkin lymphoma. It is hypothesised that lenalidomide may augment the actions of Brentuximab vedotin in these patient groups. The primary objective of the study is to determine the maximum tolerated dose of the combination treatment, which can be used in subsequent studies. The study will also investigate disease response and survival. Participants will receive Brentuximab vedotin (once every 21 days i.e. 1 cycle) and lenalidomide (daily from day 1 -14 of each cycle) for a maximum of 48 weeks and will be followed for a subsequent 6 months after the end of treatment.

Timeline

Start
2018-08-30
Primary completion
2021-08-02
Completion
2021-08-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Brentuximab Vedotin Monoclonal antibody 1.2 mg/kg Intravenous
Subject Brentuximab Vedotin Monoclonal antibody 1.8 mg/kg Intravenous
Subject Lenalidomide Other / unclassified 5 mg
Subject Lenalidomide Other / unclassified 10 mg
Subject Lenalidomide Other / unclassified 15 mg
Subject Lenalidomide Other / unclassified 25 mg