RecruitingPHASE2INTERVENTIONAL

Zanubrutinib Plus Rituximab for Patients With Indolent Mantle Cell Lymphoma

This study, called a Phase II trial, is investigating a new way to treat mantle cell lymphoma that is slow-growing (indolent). Researchers want to see if treating it early with a combination of two drugs, zanubrutinib and rituximab, given for a limited time, is better than simply watching the condition. Fifty patients will be recruited across 15 UK hospitals. Half will receive the drug combination, while the other half will be carefully monitored without treatment unless absolutely necessary. Everyone in the study will be followed up for at least two years to see how they are doing. This research aims to understand if this early treatment is safe and effective for this specific type of lymphoma.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University College, London

Enrolment target

Start

17 May 2024

Estimated completion

01 Oct 2028

Mantle Cell Lymphoma

What is this study about?

This study focuses on a specific type of cancer called Mantle Cell Lymphoma (MCL). It's particularly interested in 'indolent' MCL, which means it's a slow-growing version of the disease. Currently, for some patients with this type of MCL, doctors might choose to 'watch and wait' – carefully monitoring the condition without immediate treatment. This study wants to explore whether an early, time-limited course of treatment with two drugs, zanubrutinib and rituximab, could be a good alternative.

The main aim is to see if this combined treatment is safe and effective for people who haven't had any MCL treatment before. It’s important to find out if starting treatment earlier could improve outcomes or if 'watch and wait' remains the best approach for these patients. By comparing these two strategies, the study hopes to provide clear answers that can help doctors and patients make informed decisions in the future.

This is a 'Phase II' study, which means it's one of the earlier steps in testing new treatments. It's designed to gather more information about how well the treatment works and what side effects it might have, in a relatively small group of people. The results of this study will help decide if this new approach should be investigated further in larger trials.

Key takeaways

This study is for slow-growing Mantle Cell Lymphoma (MCL).
It compares early drug treatment with observation.
The drugs are zanubrutinib and rituximab, given for a limited time.
Participation involves regular check-ups and follow-up for at least two years.
You might receive the drugs, or you might be in the observation group.
Your health will be closely monitored throughout the study.

Who may be eligible?

To join this study, you must be at least 18 years old and have a specific type of Mantle Cell Lymphoma that is slow-growing (indolent). This means your MCL might have been watched without treatment for at least six months, or it might be a type that affects the blood and spleen without major lymph node involvement, or it's a 'low volume' type of disease. You also need to be generally well and able to carry out your normal daily activities without too much difficulty.

There are also some medical checks needed to ensure the treatment is safe for you. These include having healthy blood counts, good liver and kidney function. Women who could become pregnant will need a negative pregnancy test and agree to use effective contraception during the study. It's also crucial that you haven't received any previous treatment for your Mantle Cell Lymphoma.

You wouldn't be able to join if your MCL has spread to your brain or spinal cord, or if you have certain uncontrolled infections like HIV. The study team will review all your medical information carefully to check if you meet all the requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with a slow-growing (indolent) type of Mantle Cell Lymphoma?
Have you NOT received any previous treatment for your MCL?
Are you generally well and active with no major health issues that would prevent study participation?
Are you able to swallow capsules without difficulty?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned to one of two groups by chance (like flipping a coin). One group will receive the study drugs, zanubrutinib and rituximab, for a set period of six treatment cycles. Each cycle involves taking the medication as prescribed. The other group will be closely monitored without immediate drug treatment, which is called 'ongoing observation'.

Regardless of which group you are in, you will have regular visits to the study centre for check-ups, blood tests, and scans to see how you are doing and how your MCL is responding. For those receiving treatment, if unacceptable side effects occur or for any other reason, the treatment can be stopped early. Everyone in the study will be followed up for at least two years after they start. If a patient in the observation group or the treatment group experiences their MCL getting worse, they will then receive standard care treatment available at that time.

Potential risks and benefits

Participating in research studies like this can offer several potential benefits. You would receive close medical monitoring and access to a potential new treatment approach that may or may not be better than current established care. However, like all medications, zanubrutinib and rituximab can cause side effects. The study team will explain these potential risks in detail, and your health will be carefully monitored throughout the trial. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal Derby Hospital
Verified postcode
Derby, United Kingdom· Recruiting
Beatson West of Scotland Cancer Centre
Verified postcode
Glasgow, United Kingdom· Recruiting
Clatterbridge Cancer Centre
Verified postcode
Liverpool, United Kingdom· Recruiting
Guy's Hospital
Verified postcode
London, United Kingdom· Recruiting
St Bartholomew's Hospital
Verified postcode
London, United Kingdom· Recruiting
University College London Hospital
Verified postcode
London, United Kingdom· Recruiting
Christie Hospital
Verified postcode
Manchester, United Kingdom· Recruiting
Norfolk and Norwich University Hospitl
Verified postcode
Norwich, United Kingdom· Recruiting
Nottingham City Hospital
Verified postcode
Nottingham, United Kingdom· Recruiting
Churchill Hospital
Verified postcode
Oxford, United Kingdom· Recruiting
Derriford Hospital
Verified postcode
Plymouth, United Kingdom· Recruiting
Southampton General Hospital
Verified postcode
Southampton, United Kingdom· Recruiting

Common questions

What is 'indolent' Mantle Cell Lymphoma?

'Indolent' means slow-growing. This type of lymphoma often progresses slowly and might not need immediate treatment for some time.

What is a Phase II study?

A Phase II study is an early stage clinical trial that looks at how safe a new treatment is and how well it works in a smaller group of people, after initial safety tests.

Will I definitely get the new drugs?

No, you'll be randomly assigned to either receive the study drugs (zanubrutinib and rituximab) or be carefully observed, so there's a 50/50 chance.

How long will I be involved in the study?

All patients in the study will be followed up for at least two years after they join.

Can I stop participating if I want to?

Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

How to find out more

ZEBRA Trial Manager

ctc.zebra@ucl.ac.uk (+44) (0)2076799860 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.