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

NCT04802590 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-05-20

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • The Lymphoma Academic Research Organisation

    lead OTHER

  • Institute of Cancer Research, United Kingdom

    collaborator OTHER

Principal Investigators

  • Steven Le Gouill · Lymphoma Study Association

  • Toby Eyre · NCRI UK

  • David Lewis · NCRI UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-24
Primary Completion
2028-03-31
Completion
2031-09-30

Countries

  • Belgium
  • France
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04802590 on ClinicalTrials.gov