NCT05635162

Zanubrutinib Plus Rituximab for Patients With Indolent Mantle Cell Lymphoma

Zanubrutinib Plus Rituximab (Zanu -R) as Fixed Duration, Early Intervention Versus Observation for Patients With Indolent Mantle Cell Lymphoma: a Randomised Phase II Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

This is a phase II, multicentre, randomised open label study to assess the safety and efficacy of zanubrutinib in combination with rituximab for previously untreated indolent MCL patients. 50 patients will be recruited from 15 UK centres over 30 months. Enrolled patients will be randomised (1:1) to ongoing observation (control arm; arm A) or fixed-duration zanubrutinib-rituximab (experimental arm; arm B). Patients will discontinue zanubrutinib-rituximab after 6 cycles of therapy or sooner in the advent of unacceptable toxicity or any other reason. All patients will be followed up for a minimum of 2 years after randomisation. Patients in arm B who develop disease progression and require further therapy after the initial time-limited Zanu-R will receive standard of care therapy according to front line treatment available at that time.

Conditions

• Mantle Cell Lymphoma

Interventions

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

Timeline

• Start date: 2024-05-17
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2022-12-02
• Last updated: 2025-04-16

Locations

13 sites across 1 country: United Kingdom