Zanubrutinib Plus Rituximab for Patients With Indolent Mantle Cell Lymphoma

Sponsor
University College, London
Study ID
NCT05635162
Phase
PHASE2
Status
Recruiting
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Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zanubrutinib — DRUG
    Zanubrutinib dose is 160 mg twice daily (BD) orally (PO) on days 1-28 of each 28-day cycle.
  • Rituximab — DRUG
    Rituximab 375 mg/m2 intravenous (IV)\* on day 1 (+/-3 days) of each 28-day cycle

Study Details

Phase II, multicentre, randomised, open-label study to assess the benefit of early intervention with fixed duration, time-limited zanubrutinib-rituximab in indolent mantle cell lymphoma (MCL)

Key Dates

Start date
May 17, 2024
Status verified
Apr 2025
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Arm A: Control
    Active observation
  • Experimental: Arm B: Experimental
    Time limited Zanubrutinib-R 6 x 28 day cycles

Primary Outcome Measure

Event free survival [ Time Frame: From date of randomisation until whichever comes first: occurrence of active disease, new MCL treatment or death (any cause) up to 60 months ]

Central Contacts

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