drugset / Trial / NCT03980171

Study of Lenalidomide, Venetoclax and Obinutuzumab in Patients With Treatment-Naïve Follicular Lymphoma

NCT03980171

Phase 1/2 Active not recruiting 50 enrolled Peter MacCallum Cancer Centre, Australia
NaSingle-groupOpen-labelTreatment

Summary

The trial will investigate the combination of venetoclax, obinutuzumab and lenalidomide in patients with treatment-naïve follicular lymphoma. Patients will receive induction treatment for 0.5 years with venetoclax, obinutuzumab and lenalidomide followed by maintenance treatment for upto 2 years. Maintenance treatment will be determined by the response at the end of induction. Following completion of treatment patients will be followed up for 3 years after the last patient completes induction treatment.

Timeline

Start
2019-08-19
Primary completion
2026-11
Completion
2026-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified 10 mg
Subject Lenalidomide Other / unclassified 15 mg
Subject Lenalidomide Other / unclassified 20 mg
Subject Venetoclax Small molecule 400 mg
Subject Venetoclax Small molecule 800 mg
Background Obinutuzumab Monoclonal antibody 1000 mg Intravenous

Indications