Active not recruitingPHASE3INTERVENTIONAL

Comparison Between Rituximab Plus Zanubrutinib Versus Rituximab Monotherapy in Untreated SMZL Patients

This clinical trial is for people with a type of blood cancer called Splenic Marginal Zone Lymphoma (SMZL) who haven't been treated for it before and need treatment. The study aims to see if combining two drugs, rituximab and zanubrutinib, is more effective and just as safe as using rituximab on its own. Researchers want to understand if the combination therapy can control the lymphoma better and if patients tolerate it well. Participants will be randomly assigned to receive either the combination therapy or rituximab alone and will be followed for up to three years to monitor their health and the treatment's success.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

International Extranodal Lymphoma Study Group (IELSG)

Enrolment target

122

Start

21 May 2024

Estimated completion

01 May 2029

Splenic Marginal Zone Lymphoma

What is this study about?

This study is designed for individuals diagnosed with a specific type of slow-growing blood cancer called Splenic Marginal Zone Lymphoma, or SMZL. If you have SMZL, your doctor might explain that it affects certain white blood cells and often involves the spleen. This particular trial focuses on patients who haven't received treatment for their SMZL yet but have reached a point where treatment is now needed.

The main purpose of this research is to compare two treatment approaches. One approach uses a drug called rituximab on its own, which is a common treatment for certain lymphomas. The other approach combines rituximab with a newer drug called zanubrutinib. The researchers want to find out if taking both drugs together is more effective at controlling the SMZL than rituximab by itself, and importantly, if the combination treatment is still well-tolerated by patients. This information helps doctors understand the best ways to treat SMZL in the future.

By comparing these two treatments, the study hopes to improve how we manage SMZL. The trial will randomly assign participants to one of the two treatment groups, ensuring a fair comparison. This type of study, called a Phase 3 trial, is a crucial step in assessing new treatments before they can become widely available. It helps to confirm if a new treatment is genuinely better and safe for patients.

Key takeaways

Compares two treatment approaches for untreated SMZL.
Investigates rituximab alone versus rituximab plus zanubrutinib.
Aims to find a more effective and tolerable treatment option.
Involves regular clinic visits and monitoring for up to three years.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or over. You must have a confirmed diagnosis of SMZL, and it must be your first time receiving treatment for this condition. Your doctor will need to confirm that your SMZL fits specific criteria for the study.

There are also some general health requirements. For example, your blood tests for things like blood cell counts, liver, and kidney function need to be within a healthy range, or your doctor needs to confirm that any changes are due to your lymphoma. You also need to be well enough to carry out daily activities with little to no difficulty.

However, you wouldn't be able to join if you've already had your spleen removed or received any systemic treatment for SMZL. Certain other serious health conditions, like having had a stroke recently or some heart problems, would also mean you couldn't take part. If you've had another cancer recently, this might also exclude you, unless it was a very specific type that has been fully treated, like certain skin cancers.

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 Splenic Marginal Zone Lymphoma (SMZL)?
Have you NOT received any prior treatment for your SMZL?
Are you generally able to carry out your daily activities well?
Do you have adequate organ function as determined by blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through a 'screening' period to confirm you meet all the criteria. If you qualify, you will then be randomly assigned to one of two treatment groups: either you will receive the combination of rituximab and zanubrutinib, or you will receive rituximab on its own. You won't be able to choose which group you are in.

The treatment phase will last for up to two years. During this time, you'll have regular visits to the clinic for assessments, blood tests, and to receive your medication. If your doctors find that your lymphoma is progressing, or if you experience side effects that are too difficult to manage, you might need to stop the study treatment. After the treatment phase, there will be a 'follow-up' period that could last up to three years from when you started treatment. During this time, you'll continue to have check-ups to monitor your health and the long-term effects of the treatment, even if you stopped treatment early.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving state-of-the-art medical care and access to a new treatment combination that might be more effective than standard care. However, like any medication, the treatments in this study can have side effects, which could be mild or more serious. The study carefully monitors participants for any side effects or changes in their health. You will receive detailed information about all known risks before deciding to participate. Remember, your participation is voluntary, and you are free to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (50)

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

Medical University of Vienna
Verified postcode
Vienna, Austria
Institut Bergonié
Verified postcode
Bordeaux, France
CHU de Grenoble
Verified postcode
Grenoble, France
Hôpital Saint Louis
Verified postcode
Paris, France
Hôpital Lyon-Sud
Verified postcode
Pierre-Bénite, France
CHRU Nancy Brabois
Verified postcode
Vandœuvre-lès-Nancy, France
IRCCS Istituto Tumori Giovanni Paolo II
Verified postcode
Bari, Italy
IRCCS AOU di Bologna
Verified postcode
Bologna, Italy
ASST Spedali Civili di Brescia
Verified postcode
Brescia, Italy
A.O.U. Policlinico G. Rodolico-S. Marco
Verified postcode
Catania, Italy
IRCCS IRST Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"
Verified postcode
Meldola, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Verified postcode
Milan, Italy

Common questions

What is SMZL?

SMZL stands for Splenic Marginal Zone Lymphoma. It's a slow-growing type of cancer that affects a specific kind of white blood cell, often involving the spleen.

What are rituximab and zanubrutinib?

These are two different medications used to treat certain blood cancers. Rituximab is an antibody drug, and zanubrutinib works by blocking signals that cancer cells need to grow.

Why is this study important?

This study aims to find out if combining rituximab with zanubrutinib is a better and safer treatment option for SMZL patients compared to rituximab alone, which could improve future patient care.

Will I know which treatment I'm getting?

Yes, in this study, you will know which treatment you are receiving (either rituximab alone or rituximab with zanubrutinib). This is called an 'open-label' study.

How long will I be involved in the study?

You could be on treatment for up to two years, and then there's a follow-up period, meaning your involvement could last up to three years in total.