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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 19, 2019

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

Conditions
Follicular Lymphoma
Interventions
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.

Trial Locations (3)

3000

Peter MacCallum Cancer Centre, Melbourne

6009

Sir Charles Gairdner Hospital, Nedlands

Unknown

Townsville Hospital and Health Services, Townsville

All Listed Sponsors
lead

Peter MacCallum Cancer Centre, Australia

OTHER

NCT03980171 - Study of Lenalidomide, Venetoclax and Obinutuzumab in Patients With Treatment-Naïve Follicular Lymphoma | Biotech Hunter | Biotech Hunter