Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia)

This research study is for people who have been diagnosed with blood clots (venous thromboembolism, or VTE) and also have cancer in their digestive system (like stomach or bowel) or urinary/reproductive system. We are testing a new treatment called abelacimab. We want to see how well abelacimab works compared to dalteparin (a common blood thinner often known as Fragmin®) at stopping blood clots from coming back. We also want to check if it causes fewer bleeding problems. This study will carefully compare both treatments to find out which one is safer and more effective for preventing future blood clots in people with these types of cancer. It's a big study involving many hospitals.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Anthos Therapeutics Inc.

Enrolment target

677

Start

29 Jul 2024

venous thromboembolism (VTE) in patients with gastrointestinal/genitourinary cancer

What is this study about?

Blood clots (which doctors call venous thromboembolism or VTE) are a serious concern for people with cancer, especially those with cancers in their digestive system (like their stomach, bowel, or liver) or their urinary/reproductive system (like bladder, kidney, or prostate). These clots can be dangerous and need careful management. Currently, medicines like dalteparin are often used to thin the blood and help prevent new clots from forming.

This study is looking into a new medicine called abelacimab. We want to understand if abelacimab could be a better option for people with these specific types of cancer who have had a blood clot. The main goal is to see if abelacimab is better at stopping new blood clots from forming compared to dalteparin, and whether it causes fewer side effects, especially bleeding. Because cancer and its treatments can increase the risk of both blood clots and bleeding, finding the right balance is very important.

By comparing abelacimab with dalteparin, our aim is to find a treatment that offers excellent protection against blood clots while keeping the risk of bleeding as low as possible. This research is important because it could lead to better ways to care for people with cancer who are at risk of blood clots, helping them live healthier lives.

Key takeaways

This study compares a new medicine (abelacimab) with a standard one (dalteparin) for cancer-related blood clots.
It's for people with cancer in their digestive or urinary/reproductive systems who have experienced a blood clot.
The main goals are to see which medicine best prevents new clots and causes fewer bleeding problems.
Participation involves regular clinic visits for treatment, monitoring, and health checks.
You will be closely monitored for 6 months, and then there will be some follow-up.

Who may be eligible?

This study is looking for adults aged 18 or older. Both men and women can take part.

You would be considered for this study if you have been diagnosed with a blood clot (VTE) and also have cancer in your digestive system (like your stomach, bowel, or liver) or your urinary/reproductive system (like your bladder, kidney, or prostate).

There might be other health conditions or medicines you are taking that would mean this study isn't right for you. The study team will carefully check all your medical information to make sure it's safe and appropriate for you to join.

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 a diagnosis of a blood clot (VTE)?
Do you have cancer in your digestive system (e.g., stomach, bowel) or urinary/reproductive system (e.g., bladder, kidney)?
Are you able to attend regular hospital or clinic appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a full health check-up to see if you are suitable. If you are, you would be randomly assigned to receive either the new medicine, abelacimab, or the standard medicine, dalteparin. This is like flipping a coin – you won't get to choose which one you receive.

Both medicines are given by infusion for abelacimab or injection for dalteparin. You would have regular visits to the clinic or hospital, where the study team will monitor your health, perform blood tests, and check for any new blood clots or bleeding. They will also ask you how you are feeling and check for any side effects.

These check-ups will continue for about 6 months after you start the treatment. After this active treatment period, there will be some follow-up visits or phone calls to monitor your long-term health. The study team will explain exactly how many visits you will need and what each visit will involve.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new, experimental treatment (abelacimab) that might be more effective or have fewer side effects than current options. You will also receive careful medical monitoring throughout the study. However, like all medicines, both abelacimab and dalteparin can have side effects, including a risk of bleeding, which can be serious. There might also be unknown risks with the new medicine. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (12)

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

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Unverified
Norway
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Unverified
France
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Unverified
Hungary
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Unverified
Spain
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Unverified
Germany
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Unverified
Netherlands
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Unverified
Sweden
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Unverified
Latvia
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Unverified
Czechia
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Unverified
Austria
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Unverified
Italy
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Unverified
Ireland

Common questions

What is a 'blood clot'?

A blood clot is a lump of blood that has thickened and turned solid. In this study, we're focused on clots forming in veins, which can be serious.

What is the difference between abelacimab and dalteparin?

Dalteparin is a common blood thinner already used. Abelacimab is a new experimental medicine that works in a similar way to prevent clots, but it might have different benefits or side effects.

Why is this study important for people with cancer?

People with cancer have a higher risk of blood clots. This study aims to find a safer and more effective way to prevent these clots, which could improve their overall health.

Will I know which medicine I'm getting?

You will be randomly assigned to either abelacimab or dalteparin, but you and your doctor will know which treatment you are receiving.

How long will I be in the study?

You will receive treatment and have regular check-ups for about 6 months, with some follow-up after that phase.