50
Participants
Start Date
August 19, 2019
Primary Completion Date
November 30, 2026
Study Completion Date
November 30, 2026
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.
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.
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.
Peter MacCallum Cancer Centre, Melbourne
Sir Charles Gairdner Hospital, Nedlands
Townsville Hospital and Health Services, Townsville
Peter MacCallum Cancer Centre, Australia
OTHER