NCT03302728

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

A Phase 1b Study of Brentuximab Vedotin and Lenalidomide in Patients With Relapsed/ Refractory Cutaneous T-cell Lymphoma, CD30-positive Peripheral T-cell Lymphoma, or CD30-positive Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma, T-Cell, Cutaneous
• Lymphoma, T-Cell, Peripheral
• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Lenalidomide 15mg	At commencement of study : Lenalidomide will commence at 15 mg daily for days 1-14 of each cycle. Maximum number of cycles = 16. This is a dose finding study so doses will be adjusted depending on toxicity assessment over the course of the study. Dose may vary from 5 mg -25 mg daily depending on dose escalation results and recommendation of safety committee
DRUG	Brentuximab Vedotin 1.8 mg/Kg	At commencement of study : Brentuximab vedotin 1.8mg/kg IV on day 1, repeated every 21 days. Maximum number of cycles = 16. This is a dose finding study so doses will be adjusted depending on toxicity assessment over the course of the study. Dose may be either 1.2 mg/Kg q21 days or 1.8 mg/kg q21 days depending on dose escalation results and recommendation of safety committee

Timeline

• Start date: 2018-08-30
• Primary completion: 2021-08-02
• Completion: 2021-08-02
• First posted: 2017-10-05
• Last updated: 2022-05-19

Locations

1 site across 1 country: Australia