NCT03980171

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

A Multicenter, Open Label, Phase Ib/II Study of Lenalidomide, Venetoclax and Obinutuzumab in Patients With Treatment-Naïve Follicular Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase Ib/II (dose escalation/dose expansion), single-arm multi-centre clinical trial of venetoclax plus obinutuzumab and lenalinomide in patients with treatment-naïve follicular lymphoma. The trial involves an initial dose escalation phase followed by an expansion phase. Patients in both the dose escalation and expansion phases will receive 6 cycles of induction treatment. After patients finish induction treatment, they will undergo PET-CT scan, the results of which will determine further therapy. Patients in CR or SD/PR from the PET-CT scan result will receive up to 2 years of maintenance therapy. Patients in PD from the PET-CT result will not receive any further study treatment. All patients will be followed up for 3 years after the last patient has completed induction treatment.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Obinutuzumab	A flat dose of 1000mg IV will be given every cycle during induction. a cycle is 28 days.During maintenance 1000mg IV will be given every second cycle for upto 2 years.
DRUG	Venetoclax	During dose escalation, the doses for venetoclax can be 400mg daily days 1-10, 800mg daily days 1-10, 400mg daily continuous or 800mg daily continuous. 6 cycles of treatment will be given during induction. Once the recommended phase 2 dose (RP2D) is established that dose will be used in dose expansion. A further 6 cycles of venetoclax will be given during maintenance if required based on response at the end of induction.
DRUG	Lenalidomide	During dose escalation, the doses of lenalidomide can be 15mg for days 1-21 or 20mg for days 1-21. 6 cycles of treatment will be given during induction. During maintenance the dose of lenalidomide will be 10mg continuous for a further 6 cycles if required based on response at the end of induction.

Timeline

• Start date: 2019-08-19
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2019-06-10
• Last updated: 2024-07-29

Locations

3 sites across 1 country: Australia