RecruitingPhase 2NCT05635162

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


Sponsor

University College, London

Enrollment

50 participants

Start Date

May 17, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — zanubrutinib and rituximab — in people with a slow-growing (indolent) type of mantle cell lymphoma (MCL), a rare blood cancer. The goal is to see if this combination can control the disease without the need for aggressive chemotherapy. **You may be eligible if...** - You are 18 years or older - You have been confirmed to have mantle cell lymphoma with specific genetic markers - Your MCL is classified as "indolent" — meaning it is growing slowly and not causing severe symptoms - Your cancer is stage II–IV **You may NOT be eligible if...** - You have an aggressive form of mantle cell lymphoma - Your MCL does not have the required genetic marker (chromosome translocation or cyclin overexpression) - Your expected survival is less than 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGZanubrutinib

Zanubrutinib dose is 160 mg twice daily (BD) orally (PO) on days 1-28 of each 28-day cycle.

DRUGRituximab

Rituximab 375 mg/m2 intravenous (IV)\* on day 1 (+/-3 days) of each 28-day cycle


Locations(13)

Royal Derby Hospital

Derby, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Clatterbridge Cancer Centre

Liverpool, United Kingdom

Guy's Hospital

London, United Kingdom

St Bartholomew's Hospital

London, United Kingdom

University College London Hospital

London, United Kingdom

Christie Hospital

Manchester, United Kingdom

Norfolk and Norwich University Hospitl

Norwich, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom

Churchill Hospital

Oxford, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

Royal Cornwall Hospital

Truro, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05635162


Related Trials