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

Sponsor
The Lymphoma Academic Research Organisation
Study ID
NCT04802590
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 24, 2022
Status verified
May 2026
Primary completion
Mar 31, 2028
Completion
Sep 30, 2031

Study Design

Enrollment
210 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Ibrutinib (+ CD20Ab)
  • Experimental: Arm B
    Ibrutinib + Venetoclax (+CD20Ab)

Primary Outcome Measure

Minimum residual disease (MRD) rate [ Time Frame: 6 months ]

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