Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Study of safety and preliminary efficacy of VAY736 given alone or in combination with other antineoplastic agents in patients with NHL

This research study is about a new drug, VAY736, for adults with a specific blood cancer called Non-Hodgkin Lymphoma. This is for people whose cancer has returned after treatment or hasn't improved with other medicines. The main goals are to check if VAY736 is safe to use and to get an early idea of how effective it might be. Doctors will either give VAY736 on its own or combine it with other medicines already used for cancer. This is an early-stage study, which means it’s one of the first times this drug is being tested in people. This kind of research is very important for finding new ways to treat cancer in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Novartis Pharma AG

Enrolment target

Start

02 Jul 2024

Relapsed/refractory Non Hodgkin Lymphoma

What is this study about?

This study is looking into a new treatment called VAY736 for a type of cancer known as Non-Hodgkin Lymphoma. If you or someone you know has been diagnosed with Non-Hodgkin Lymphoma, you might be familiar with the challenges when the cancer comes back after treatment, or if it doesn't respond to the usual medicines. This type of cancer is then called 'relapsed' or 'refractory'.

The main purpose of this research is to see if VAY736 is safe for people to take, and to get an early idea of how well it works. This is one of the very first studies of VAY736 in humans, often called a 'Phase 1' study. Researchers are testing VAY736 in two ways: some patients will receive VAY736 on its own, while others will get it alongside other cancer drugs they might already be taking. This helps the researchers understand the best way to use this new medicine.

Finding new and better ways to treat Non-Hodgkin Lymphoma is really important. Studies like this help doctors learn more about promising new treatments. While this is an early-stage study, the information gathered will help decide if VAY736 should be tested in larger studies in the future, potentially leading to new options for patients.

Key takeaways

This study is for adults with Non-Hodgkin Lymphoma that has come back or isn't responding to treatment.
It's testing a new drug called VAY736, either alone or with other cancer medicines.
The main aims are to check the drug's safety and get an early idea of how well it works.
This is an early-stage (Phase 1) study.
You must be at least 18 years old to take part; there is no upper age limit.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. There is no upper age limit, meaning older adults can also take part. Both men and women are welcome to participate.

The study is specifically for people who have Non-Hodgkin Lymphoma. This means your cancer must have either come back after you’ve already had treatment, or it hasn't responded to the treatments you’ve tried so far. This type of cancer is called 'relapsed/refractory' Non-Hodgkin Lymphoma.

There will be other health checks and requirements that your doctor will discuss with you to make sure the study is a safe option for you. These checks are important to protect your health while you are taking part.

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?
Do you have Non-Hodgkin Lymphoma that has relapsed (come back) or is refractory (not responding to treatment)?
Are you able to attend regular hospital appointments and tests?
Are you willing to potentially receive a new, experimental drug?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first have a number of tests. These help the doctors understand your health and cancer history to make sure you are a good fit for the study. If you meet the criteria, you would then start receiving the study treatment, VAY736. Depending on which group you are in, you might receive VAY736 on its own or with other medicines.

You would need to attend regular appointments at the hospital or clinic. These visits would involve detailed check-ups, blood tests, and scans to monitor your health, how you are responding to the treatment, and to look for any side effects. The study team would explain the schedule of these visits and what each involves. You would also have follow-up visits after your treatment ends to continue monitoring your health. The total time you would be involved in the study would depend on how you respond to the treatment and the study plan, but it could range from several months to longer, including follow-up phases.

Potential risks and benefits

Taking part in a research study like this offers the chance to try a new treatment that isn’t widely available yet, which might help your condition. However, it's important to remember that because this is an early-stage study, we don't fully know all the possible side effects or how effective the treatment will be. There might be risks involved, and you could experience side effects from the study drug or the combination treatments. These will be fully explained to you before you decide to take part. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Germany
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Unverified
Italy
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Unverified
Spain

Common questions

What is Non-Hodgkin Lymphoma?

Non-Hodgkin Lymphoma is a type of cancer that starts in white blood cells called lymphocytes, which are part of your immune system. It can develop in the lymph nodes, spleen, bone marrow, or other organs.

What does 'relapsed/refractory' mean?

This means your cancer has either come back after previous treatment (relapsed), or it hasn't responded to the treatments you've already tried (refractory).

What is a 'Phase 1' study?

A Phase 1 study is an early stage of human testing for a new drug. Its main goals are to check if the drug is safe, to find the best dose, and to see how the body handles it, rather than focusing on how well it treats the disease yet.

Will I definitely get the new drug VAY736?

Yes, if you qualify for this study, you will receive VAY736. Some patients will get it alone, and others will get it with other cancer medicines.

What if I feel unwell during the study?

The study team will closely monitor you. You will have a contact number to call at any time if you experience side effects or feel unwell. Your safety is their top priority.