Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

C5691004 _ A dual-cohort, open-label, phase 2 study of brentuximab vedotin and CHP (A+CHP) in the frontline treatment of subjects with peripheral T-cell lymphoma (PTCL) with less than 10% CD30 expression

This study is looking at a new treatment combination for a type of cancer called peripheral T-cell lymphoma (PTCL). This cancer affects certain white blood cells. The researchers are combining a drug called brentuximab vedotin with a standard chemotherapy treatment known as CHP. They want to see how effective this new combination is in people whose cancer cells have a particular marker (CD30) at low levels. The main goal is to find out if the cancer shrinks or disappears after treatment. This is a Phase 2 study, meaning it's still in the earlier stages of testing new treatments, focusing on whether it works and is safe. It's for adults aged 18 and over.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Seagen Inc.

Enrolment target

Start

15 Dec 2023

Peripheral T-cell Lymphoma

What is this study about?

This study is about finding better ways to treat a type of cancer called peripheral T-cell lymphoma, often shortened to PTCL. This is a rare cancer that affects a specific kind of white blood cell in your body.

The study treatment involves combining a newer drug, called brentuximab vedotin, with a standard chemotherapy treatment that doctors already use. This standard chemotherapy is known by the letters CHP, which stands for a mix of drugs including Prednisone, Doxorubicin, and Cyclophosphamide. The researchers are particularly interested in patients whose cancer cells have a certain marker called CD30, but only in small amounts (less than 10%). They want to see if this new combination of drugs works well for these patients. The study is open-label, meaning both you and the study team will know which treatment you are receiving.

The main thing the doctors want to find out is how many patients respond to the treatment, meaning their cancer shrinks or disappears after taking the medication. This is known as the 'Overall Response Rate'. They will also be looking at other important aspects, such as how long people live without their cancer getting worse, how long they live overall, and if the cancer's response lasts for a long time. Equally important, they will carefully monitor any side effects to make sure the treatment is safe.

Key takeaways

This study investigates a new treatment for Peripheral T-cell Lymphoma (PTCL).
It combines a newer drug, brentuximab vedotin, with standard chemotherapy (CHP).
The focus is on PTCL patients with less than 10% CD30 expression.
Researchers want to see if the cancer shrinks or disappears (Overall Response Rate).
It's a Phase 2 study, focusing on effectiveness and safety in a small group.
Participation carries both potential benefits and risks of side effects.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women can take part. The study is specifically for people who have been diagnosed with peripheral T-cell lymphoma (PTCL).

Also, your specific type of PTCL needs to have a particular marker called CD30 present, but at low levels – less than 10% on your cancer cells. There will be other health checks and requirements that the study doctors will go through with you to make sure it's safe for you to take 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?
Have you been diagnosed with Peripheral T-cell Lymphoma (PTCL)?
Has your doctor confirmed that your PTCL has less than 10% CD30 expression?
Are you able to attend regular hospital visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive a combination of medicines. These include brentuximab vedotin along with the chemotherapy drugs Prednisone, Doxorubicin, and Cyclophosphamide. These medicines are usually given as injections or infusions (drips) into your vein, and some might be tablets, like Prednisone.

You would have regular appointments with the study team. During these visits, the doctors and nurses would check your health, see how you're responding to the treatment, and monitor for any side effects. This would involve physical exams, blood tests, and scans to see how the cancer is reacting. The study aims to follow your progress throughout the treatment and for a period afterwards to fully understand the effects of the new combination.

Potential risks and benefits

Taking part in a clinical trial might offer the potential benefit of accessing a new treatment that isn't yet widely available, and it could help doctors learn more about your type of cancer. However, all medications can have side effects, and the combination in this study might cause various reactions, some of which could be serious. The study team will explain all known side effects and monitor you closely. You are always free to leave 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
Spain
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Unverified
Italy
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Unverified
France

Common questions

What is peripheral T-cell lymphoma (PTCL)?

PTCL is a rare type of cancer that affects a specific kind of white blood cell called T-cells, which are part of your immune system.

What does 'Phase 2 study' mean?

Phase 2 means it's an earlier stage of testing a new treatment. Researchers are looking to see if the treatment works and is safe, after basic safety checks in Phase 1.

What are the main drugs being tested?

The study is testing a combination of brentuximab vedotin with standard chemotherapy (Cyclophosphamide, Doxorubicin, and Prednisone, sometimes called CHP).

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, which means both you and your study team will know you are receiving the brentuximab vedotin plus CHP combination.

What does 'low CD30 expression' mean?

It means your cancer cells have a particular marker (CD30) on them, but only in small amounts (less than 10%). This study is specifically looking at treatments for PTCL patients with this characteristic.