NCT04802590

Study of Ibrutinib + CD20 Antibody and Venetoclax in Patients With Untreated Mantle Cell Lymphoma

A Randomized Phase II Trial Evaluating Ibrutinib Plus CD20 Ab and Venetoclax in Patients With Untreated Mantle Cell Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 194 (estimated)
• Sponsor: The Lymphoma Academic Research Organisation · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The OASIS II trial is a multicentre, open label, randomized phase II trial. We will compare the efficacy of Ibrutinib/anti-CD20 Ab versus Ibrutinib/anti-CD20 Ab/Venetoclax given as fixed duration combinations in newly diagnosed Mantle Cell Lymphoma (MCL) patients (≥ 18 years and \< 80 years of age). Treatment duration of Ibrutinib and Venetoclax will be a maximum of two years. Patients will be treated with CD20 Ab for 3.5 years. The primary aim is to assess MRD status at 6 months in both arms.

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib 560 mg	560mg/d continuously from C1D2 to end C24
DRUG	Venetoclax 10 MG Oral Tablet [Venclexta]	20mg/d from C2D1 to C2D7
DRUG	Venetoclax 50 MG Oral Tablet [Venclexta]	50mg/d from C2D8 to C2D14
DRUG	Venetoclax 100 MG Oral Tablet [Venclexta]	100mg/d from C2D15 to C2D21 200mg/d from C2D22 to C2D28 400mg/d from C3D1 to end C24

Timeline

• Start date: 2022-01-24
• Primary completion: 2026-03-31
• Completion: 2031-09-30
• First posted: 2021-03-17
• Last updated: 2026-03-04

Locations

45 sites across 3 countries: Belgium, France, United Kingdom