Active not recruitingPHASE1, PHASE2INTERVENTIONAL

An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

This study is for adults with Non-Hodgkin's Lymphoma where treatment hasn't worked or the cancer has returned. It's testing new combinations of medicines like Glofitamab, Atezolizumab, and Polatuzumab Vedotin. The main goals are to find the right and safest dose of these drug combinations, understand their side effects, and see if they can help fight the cancer. There's also a part of the study (an 'imaging sub-study') using a special scan to look at immune cells before and after treatment to understand how the drugs work. This is an early-stage trial, designed to gather important information for future treatments.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Hoffmann-La Roche

Enrolment target

211

Start

08 May 2018

Estimated completion

16 Oct 2026

Non-Hodgkins Lymphoma

What is this study about?

This study is looking into new ways to treat a type of cancer called B-cell Non-Hodgkin's Lymphoma. This is a cancer that affects certain white blood cells and is part of your immune system. The trial is for people whose cancer has either come back after treatment or hasn't responded to their previous treatments.

The main aim of this study is to test new combinations of medicines. These include drugs like Glofitamab, Atezolizumab, and Polatuzumab Vedotin. Researchers want to find out the safest and most effective dose for these combinations. They will also be closely watching for any side effects and seeing how well these treatments work against the cancer. This is an 'open-label' study, meaning both you and your doctors will know which treatment you are receiving.

There's also an optional part of the study which involves special scans. These scans use a 'tracer' (a mildly radioactive substance) to help doctors see certain immune cells called CD8+ T-cells before and after treatment. This helps them understand how the new medicines are affecting your immune system and fighting the cancer.

Key takeaways

This study is testing new drug combinations for B-cell Non-Hodgkin's Lymphoma.
It's for people whose cancer has returned or didn't respond to previous treatments.
The main goals are to find the right dose, check safety, and see if the treatments work.
There's an optional part using special scans to understand how the drugs affect immune cells.
Participation involves regular clinic visits, blood tests, and scans.
You can stop participating in the study at any time if you wish.

Who may be eligible?

To join this study, you would need to be an adult with a type of Non-Hodgkin's Lymphoma that has either returned or not responded to at least one previous treatment. Your doctors should believe that there are no standard treatments left that would likely help you, or you might have chosen not to have them.

Your medical records would need to show that you have specific types of Non-Hodgkin's Lymphoma, like Diffuse Large B-cell Lymphoma or Follicular Lymphoma, amongst others. You also need to have at least one area of cancer that can be measured by scans. Your general health should be good enough to take part, meaning your major organs like your liver, kidneys, and blood system are working well.

There are also some reasons why you might not be able to join. For example, if you have certain other types of blood cancers, or if you have specific infections like hepatitis B or C, or HIV. If you're in the group receiving Polatuzumab Vedotin, you can't have numbness or tingling in your hands or feet that's worse than mild.

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 an adult (18 years or older)?
Do you have a type of B-cell Non-Hodgkin's Lymphoma that has returned or not responded to past treatments?
Do you have at least one measurable area of cancer that scans can pick up?
Is your general health, including your organ function, considered good enough by your doctor?
Do you *not* have certain other types of blood cancer like Burkitt lymphoma?
Are you free of certain infections like Hepatitis B/C or HIV?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive one of the new drug combinations being tested. The study involves regular visits to the clinic for treatments, blood tests, and scans to monitor your health and how the treatment is working. Some participants might also undergo an additional part of the study which includes special scans and providing two extra tumour biopsies (small tissue samples) – one before treatment and one during treatment. The total length of your participation will depend on how you respond to the treatment and what the study doctors advise.

Potential risks and benefits

Taking part in a clinical trial may offer the potential benefit of accessing new treatments before they are widely available, which could help your condition. However, there are also potential risks, as these are new combinations of medicines and their full range of side effects might not be completely known. You might experience side effects from the drugs, and there's no guarantee the treatment will work for you. Your safety will be closely monitored throughout the study, and you are free to withdraw from the study at any time without affecting your future medical care.

Locations (19)

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

UZ Gent
Verified postcode
Ghent, Belgium
Aarhus Universitetshospital Skejby
Verified postcode
Aarhus N, Denmark
Rigshospitalet
Verified postcode
København Ø, Denmark
Odense Universitetshospital
Verified postcode
Odense C, Denmark
Hadassah Ein Karem Hospital
Verified postcode
Jerusalem, Israel
Rabin Medical Center-Beilinson Campus
Verified postcode
Petah Tikva, Israel
Chaim Sheba Medical Center
Verified postcode
Ramat Gan, Israel
Istituto Nazionale Tumori Irccs Fondazione g. Pascale
Verified postcode
Naples, Italy
Policlinico S.Orsola-Malpighi
Verified postcode
Bologna, Italy
Asst Papa Giovanni Xxiii
Verified postcode
Bergamo, Italy
Fond. IRCCS Istituto Nazionale Tumori
Verified postcode
Milan, Italy
Hospital Universitari Vall d'Hebron
Verified postcode
Barcelona, Spain

Common questions

What is Non-Hodgkin's Lymphoma?

It's a type of cancer that starts in white blood cells called lymphocytes, which are part of your body's immune system.

What does 'relapsed/refractory' mean?

It means your cancer has either come back after treatment (relapsed) or didn't respond to previous treatments (refractory).

What is an 'open-label' study?

It means both you and your study doctors will know which specific treatment you are receiving.

What is a 'Phase I/II' study?

These are early-stage studies. Phase I focuses on finding the safest dose and understanding side effects. Phase II looks at how well the treatment works while still checking for safety.

Will I get a placebo?

No, this study does not use a placebo. All participants will receive active study treatments.