Active not recruitingPHASE2INTERVENTIONAL

Study of Ibrutinib + CD20 Antibody and Venetoclax in Patients With Untreated Mantle Cell Lymphoma

This research study, called OASIS II, is for people with Mantle Cell Lymphoma who haven't had treatment before. It's a Phase 2 trial comparing two different combinations of medicines. One group of patients will receive Ibrutinib and a special antibody called CD20. The other group will get these two medicines plus a third drug called Venetoclax. The main goal is to see which combination is better at getting rid of very small amounts of cancer cells after six months. Taking part could involve taking medications and having check-ups for up to 3.5 years. It's for adults aged 18 to 79.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

The Lymphoma Academic Research Organisation

Enrolment target

210

Start

24 Jan 2022

Estimated completion

30 Sep 2031

Mantle Cell Lymphoma

What is this study about?

This study, called OASIS II, is designed for people who have recently been diagnosed with a type of blood cancer called Mantle Cell Lymphoma and haven't started treatment yet. It's a 'Phase 2' study, which means researchers are carefully checking if new combinations of existing drugs are safe and effective. The main aim is to find better ways to treat this cancer.

In this study, doctors want to compare two different treatment plans. Both plans include a drug called Ibrutinib and an antibody therapy that targets cells with a specific marker called CD20. The key difference is that one group will also receive an additional drug called Venetoclax. By comparing these two approaches, researchers hope to discover if adding Venetoclax leads to better outcomes for patients.

The main thing doctors will be looking for is how well the treatments get rid of the cancer, even down to tiny amounts that can't be seen easily (this is called 'minimal residual disease' or 'MRD'). They will specifically check this after six months of treatment. Patients will take these medicines for a set period, and there will be regular check-ups to see how they are doing.

Key takeaways

This study is for people with newly diagnosed Mantle Cell Lymphoma.
It compares two different drug combinations, one with three drugs and one with two.
The main aim is to see if adding Venetoclax improves how well treatment works.
Participation involves taking medicines and regular check-ups for up to 3.5 years.
It's for adults aged 18 to 79.
All participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 79 years old and have a confirmed diagnosis of Mantle Cell Lymphoma that hasn't been treated yet. Your doctors will need to confirm the specific type of lymphoma you have.

You'll also need to be generally well enough to take part, with your kidneys and liver working properly, and your cancer should be at a certain stage (Stage II-IV) and considered to need treatment. Your doctor will also assess your overall health and how well you can go about your daily activities.

There are also some things that would prevent you from joining. For example, if you have certain serious heart problems or other significant health conditions that could make the treatment unsafe. Women who can have children will need to use effective birth control during and for some time after the study, and men will also need to use birth control.

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 between 18 and 79 years old?
Have you been diagnosed with Mantle Cell Lymphoma recently?
Have you NOT received any prior treatment for your lymphoma?
Do you have suitable kidney and liver function?
Is your overall health good enough for you to take part?
Are you willing to use effective birth control if needed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of two treatment groups. Both groups will receive Ibrutinib and an anti-CD20 antibody. One group will also receive Venetoclax. The Ibrutinib and Venetoclax would be taken for up to two years, while the CD20 antibody treatment would continue for up to 3.5 years.

Throughout the study, you'll have regular hospital visits. During these visits, doctors and nurses will check your health, give you the study medications, and perform tests like blood tests, scans, and possibly bone marrow biopsies to see how you're responding to treatment and to monitor for any side effects. The exact schedule of visits and tests will be explained to you in detail. The total time you'd be involved in the study, including follow-up, could be up to 3.5 years.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing new or different treatment approaches for your condition before they are widely available, which might be more effective. However, there are also potential risks, as the treatments could cause side effects, some of which might be serious or unexpected. The study team will monitor you closely for any issues, and you will be fully informed about known possible side effects before you decide to join. Remember, taking part in any clinical trial is completely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (45)

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

A.Z. Sint Jan AV
Verified postcode
Bruges, Belgium
Universite Libre de Bruxelles - Hopital ERASME
Verified postcode
Brussels, Belgium
Hopital Jolimont
Verified postcode
Haine-Saint-Paul, Belgium
CHU de Liege
Verified postcode
Liège, Belgium
Universite Catholique de Louvain Mont Godinne
Verified postcode
Yvoir, Belgium
CHU d'Angers
Verified postcode
Angers, France
CH d'Avignon - Hopital Henri Duffaut
Verified postcode
Avignon, France
CH de la Côte Basque
Verified postcode
Bayonne, France
CHU Jean Minioz
Verified postcode
Besançon, France
Chu de Brest - Hopital de La Cavale Blanche
Verified postcode
Brest, France
Institut d'Hématologie de Basse Normandie
Verified postcode
Caen, France
Chu Estaing
Verified postcode
Clermont-Ferrand, France

Common questions

What is Mantle Cell Lymphoma?

Mantle Cell Lymphoma is a rare type of cancer that affects a specific kind of white blood cell, which are part of your immune system.

What do the drugs Ibrutinib and Venetoclax do?

These are targeted therapies that work in different ways to stop lymphoma cells from growing and surviving.

What does 'untreated' mean in this study?

It means you haven't received any prior treatment specifically for your Mantle Cell Lymphoma.

What is a 'CD20 antibody'?

It's a type of medicine that helps your immune system find and destroy cancer cells that have a specific marker called CD20 on their surface.

Will I know which treatment group I'm in?

Yes, this is an 'open-label' study, so you and your study doctor will know which combination of treatments you are receiving.