AuthorisedTherapeutic confirmatory (Phase III)Interventional

BeCALM - Brentuximab vedotin in CutAneous T-cell Lymphomas (CTCL): post-allogeneic hematopoietic stem cell transplant Maintenance

This study, called BeCALM, is for people with a rare skin cancer called cutaneous T-cell lymphoma (CTCL). After having a special type of transplant called an allogeneic hematopoietic stem cell transplant, some people's cancer can come back. This study is testing if a medicine called Adcetris can help prevent the cancer from returning during the two years after their transplant. Half the participants will receive Adcetris, and the other half will receive a dummy treatment (placebo). No one, not even the doctors, will know who is getting which treatment. We will closely watch how long people stay cancer-free and also look at their quality of life. This is a very important study to see if Adcetris can improve long-term outcomes for patients.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

19 Aug 2025

rare disease

What is this study about?

This study, called BeCALM, is designed for individuals who have a specific type of rare skin cancer known as cutaneous T-cell lymphoma (CTCL). This kind of cancer affects white blood cells that normally help your body fight infection, but in CTCL, they start to grow abnormally in your skin. A common and sometimes effective treatment for this can be a special kind of transplant called an allogeneic hematopoietic stem cell transplant. This transplant replaces unhealthy blood-forming cells with healthy ones from a donor. While this can be very helpful, sometimes the cancer can still come back.

The main goal of the BeCALM study is to see if a medication called Adcetris can help prevent the cancer from returning after this type of transplant. We want to find out if taking Adcetris for some time after the transplant can keep people free from cancer for longer. Researchers will be looking mainly at how many people stay cancer-free for two years after starting the study. They will also be very interested in overall survival and how taking Adcetris affects your day-to-day life and well-being.

To make sure the results are as fair and accurate as possible, this study is designed in a special way. Some participants will receive Adcetris, while others will receive a 'dummy' treatment called a placebo, which looks just like the real medicine but contains no active drug. Neither you nor your doctors will know which treatment you are receiving (this is called a 'double-blind' study). This helps us truly understand if any changes are due to the Adcetris itself and not other factors. The information gathered from this study could help doctors in the future decide on the best ways to care for people with CTCL after their transplant.

Key takeaways

This study evaluates Adcetris to prevent CTCL relapse after transplant.
It's for adults with cutaneous T-cell lymphoma after an allogeneic stem cell transplant.
Participants will receive either Adcetris or a placebo.
The study aims to see if Adcetris helps patients stay cancer-free longer.
Your health and quality of life will be carefully monitored.
It's a 'double-blind' study, meaning key individuals won't know who receives which treatment.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

Specifically, you must have been diagnosed with cutaneous T-cell lymphoma (CTCL). You would also need to have recently undergone a specific type of treatment called an allogeneic hematopoietic stem cell transplant. This study is focused on what happens after this transplant.

The research team will have a detailed list of other medical conditions or treatments that might make someone unsuitable for the study, to ensure it's safe for everyone involved. Your doctor will be able to check these in detail with you.

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 cutaneous T-cell lymphoma (CTCL)?
Have you recently had an allogeneic hematopoietic stem cell transplant?
Are you willing to potentially receive either the study drug or a placebo?
Are you able to attend regular clinic visits and follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would primarily receive either the study drug, Adcetris, or a placebo (a dummy treatment) through an injection into your vein. This would happen regularly, likely over a period of time after your stem cell transplant. Because it's a 'double-blind' study, neither you nor your doctor would know if you are receiving Adcetris or the placebo. You would have regular visits to the clinic for these treatments and check-ups. During these visits, the medical team will assess your health, monitor your cancer, and ask you questions about how you are feeling and your quality of life. They will be particularly interested in whether your cancer returns. The main follow-up for the study will last for two years, where they will specifically track if the cancer progresses or not, but you may be followed for longer to see the full impact on your overall health and well-being. There will also be tests to look at your skin and other measurements to understand the effects of the treatment.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. A potential benefit of joining this study is that if you receive Adcetris, it might help prevent your cutaneous T-cell lymphoma from returning after your stem cell transplant, potentially improving your long-term health. However, there's also a chance you could receive the placebo, which has no active drug. Adcetris, like all medications, can have side effects, and some common side effects include feeling tired, sickness, or nerve problems. The doctors and nurses will monitor you very closely for any side effects and manage them as best they can. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is cutaneous T-cell lymphoma?

It's a rare cancer that starts in certain white blood cells and mainly affects the skin, causing rashes or lesions.

What is a stem cell transplant?

It's a treatment that replaces unhealthy blood-forming cells with healthy ones, often from a donor, to help fight certain cancers.

What does 'double-blind' mean?

It means neither you nor your doctors will know if you're getting the active drug (Adcetris) or the dummy treatment (placebo).

What is the main goal of this study?

The main goal is to see if Adcetris can help prevent the cancer from coming back for two years after a stem cell transplant.

Will my quality of life be looked at?

Yes, how you feel and your quality of life will be checked at different times during the study.