OASIS II - A randomized phase II trial evaluating Ibrutinib plus CD20 Ab and Ibrutinib-Venetoclax plus CD20 Ab in patients with untreated mantle cell lymphoma

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512634-15-00

Acronym

Oasis II

Enrollment

Registered

2024-05-21

Start date

2022-01-05

Completion date

Unknown

Last updated

2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with untreated mantle cell lymphoma

Brief summary

The primary endpoint is the MRD negativity rate at the end of induction (after 6 cycles) in the informative MRD set using ddPCR technique. We expect to have an increase of 12% of the MRD negativity rate in each arm.

Detailed description

PFS at 3 years. We expect to have an increase of 10% of the PFS at 3 years in each arm.

Interventions

DRUGIBRUTINIB

DRUGVENETOCLAX

DRUGRITUXIMAB

DRUGOBINUTUZUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
PFS at 3 years. We expect to have an increase of 10% of the PFS at 3 years in each arm.	—

Primary

Measure	Time frame
The primary endpoint is the MRD negativity rate at the end of induction (after 6 cycles) in the informative MRD set using ddPCR technique. We expect to have an increase of 12% of the MRD negativity rate in each arm.	—

Countries

Belgium, France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026