Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2 Open-label Study of Loncastuximab Tesirine in Combination with Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Patients with Diffuse Large B-cell Lymphoma (DLBCL) (LOTIS-9)

This research study, called LOTIS-9, is looking at a new combination of medicines, Loncastuximab Tesirine and Rituximab, for a specific type of blood cancer called Diffuse Large B-cell Lymphoma (DLBCL). This type of lymphoma is aggressive and needs treatment. The study is for people who are newly diagnosed with DLBCL, haven't been treated for it before, and might be considered 'unfit' or 'frail', meaning standard forceful treatments might be too much for them. Researchers want to find out how well the new combination shrinks the cancer and how safe it is for these particular patients, especially looking at how many people have their cancer completely disappear and how well they tolerate the treatment over time. The study is in its second phase, meaning it's still an early investigation into the medicine's effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

ADC Therapeutics S.A.

Enrolment target

Start

27 Feb 2023

Diffuse large B-cell Lymphoma

What is this study about?

This study is exploring a new way to treat Diffuse Large B-cell Lymphoma (DLBCL). DLBCL is a fast-growing cancer of certain white blood cells. For many people, existing treatments work well. However, some people, particularly those who are older or have other health problems, might find the standard strong treatments too difficult to cope with. This study is specifically for these individuals, often described as 'unfit' or 'frail', who haven't had treatment for their DLBCL before.

The main goal of this study is to see if a new combination of medicines, Loncastuximab Tesirine and Rituximab (which is already known as Truxima), can effectively shrink or get rid of the cancer in these patients. Researchers are especially interested in the number of people whose cancer completely disappears. They also want to understand how well people can tolerate the treatment and what side effects they might experience. This information is crucial for determining if this new combination could be a good treatment option for this specific group of patients.

This is a Phase 2 study, which means it builds on earlier research but is still focused on understanding how safe the treatment is and how well it works. It's an important step in potentially finding kinder and more effective treatments for people with DLBCL who may not be able to undergo standard, more intensive therapies.

Key takeaways

This study is for newly diagnosed DLBCL patients who cannot take standard strong treatments.
It tests a new combination of medicines: Loncastuximab Tesirine and Rituximab (Truxima).
The main goals are to see how well the treatment shrinks the cancer and if it's safe.
Participation involves regular clinic visits for infusions and health checks.
You have the right to leave the study at any time if you choose.

Who may be eligible?

To be considered for this study, you would need to have Diffuse Large B-cell Lymphoma and not have received any previous treatment for it. The study is specifically designed for people who might be considered 'unfit' or 'frail', meaning your doctor believes standard, strong treatments might be too much for your body to handle.

There are no specific age limits; people of all adult ages could potentially join if they meet the other criteria. The study welcomes both men and women.

Your doctor would assess your overall health and medical history very carefully to make sure this study is right for you and that you meet all the necessary requirements to participate safely.

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.

Have you been diagnosed with Diffuse Large B-cell Lymphoma?
Have you *not* received any prior treatment for your lymphoma?
Has your doctor said you might be too 'unfit' or 'frail' for standard, aggressive lymphoma treatments?
Are you willing to attend regular appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the new combination treatment, which involves infusions of Loncastuximab Tesirine and Rituximab (Truxima). The treatment will be given in cycles, and the study specifically looks at how people manage over at least four cycles of treatment. You would have regular visits to the clinic for your infusions and to have your health checked.

During these visits, healthcare professionals would monitor your progress very closely. This would include tests to see how your cancer is responding to the treatment, blood tests to check your general health, and discussions about any side effects you might be experiencing. They would also ask about your overall well-being, including any symptoms you have and how you're feeling day-to-day, using questionnaires. The total length of your participation would depend on how your cancer responds to the treatment and your overall health, with follow-up appointments to monitor your health for a few years after treatment ends.

Potential risks and benefits

Participating in this study might offer the potential benefit of a new treatment option for your cancer, especially if standard options are not suitable for you. This treatment might help shrink or even get rid of your lymphoma. However, like all medicines, there can be potential risks and side effects, and these will be carefully monitored by the study team. You will be given full information about these potential risks. Remember, taking part in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Italy
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Unverified
Spain

Common questions

What is Diffuse Large B-cell Lymphoma (DLBCL)?

DLBCL is an aggressive type of cancer that affects a specific kind of white blood cell called B-cells. These cells are part of your immune system.

What does 'unfit/frail' mean in this study?

It means the study is for people who might be older or have other health issues that make strong, standard cancer treatments too difficult or risky for them.

What are Loncastuximab Tesirine and Rituximab?

These are the medicines being tested together. Rituximab (Truxima) is a commonly used cancer drug, and Loncastuximab Tesirine is a newer drug being combined with it.

What is an 'infusion'?

An infusion means the medicine is given slowly into your bloodstream, usually through a drip in your arm.

Will I get a sugar pill (placebo)?

No, this study does not involve a placebo. Everyone in the study will receive the active study treatment combination.