Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized, Controlled, Open-label, Multicenter, Inferentially Seamless Phase 2/3 Study of Ibrutinib in Combination With Rituximab Versus Physician’s Choice of Lenalidomide Plus Rituximab or Bortezomib Plus Rituximab in Participants with Relapsed or Refractory Mantle Cell Lymphoma

This study is for adults with a type of blood cancer called mantle cell lymphoma. This is when the cancer has either returned after being treated before, or didn't get better with previous treatments. The study aims to find the best way to treat this condition. We are comparing two different treatment approaches. One group of patients will receive a drug called Ibrutinib. The other group will receive one of two commonly used treatments: Lenalidomide or Bortezomib. All patients in the study will also receive Rituximab, which is a standard cancer treatment. By comparing these options, researchers hope to discover which treatment combination is most effective and safe, ultimately improving care for people with this type of lymphoma.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Janssen - Cilag International

Enrolment target

Start

17 Nov 2023

Relapsed/Refractory Mantle Cell Lymphoma

What is this study about?

This study is focused on a specific type of cancer called mantle cell lymphoma. This is a cancer that affects a type of white blood cell called B-cells. For this study, we are looking at situations where the cancer has either come back after someone has already had treatment, or where the first treatments didn't work as well as hoped. This is often called 'relapsed or refractory' cancer.

The main goal is to find out which treatment combination works best for these patients. The study compares two different approaches. One group of patients will receive a medicine called Ibrutinib. The other group will receive one of two common treatments that doctors might choose: either Lenalidomide or Bortezomib. All patients in the study, regardless of which main drug they receive, will also be given Rituximab, which is another important drug in cancer treatment.

By carefully comparing these different treatment plans, the researchers hope to identify which combination is most effective at controlling the cancer and improving patients' health. This kind of research is vital because it helps doctors make better decisions about how to treat mantle cell lymphoma in the future, especially when it has been difficult to treat before.

Key takeaways

Compares two treatment approaches for mantle cell lymphoma that has returned or is hard to treat.
Investigates Ibrutinib plus Rituximab versus standard options (Lenalidomide or Bortezomib) plus Rituximab.
For adults 18 years and older, both men and women.
Aims to find a more effective treatment for this specific type of lymphoma.
Participation involves regular medical check-ups and close monitoring.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older – there's no upper age limit. Both men and women can take part.

Specifically, you must have a diagnosis of mantle cell lymphoma that has either come back after previous treatment, or didn't respond adequately to earlier treatments. The doctors running the study will carefully check your medical records and perform some tests to make sure that other aspects of your health are suitable for you 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.

Are you 18 years old or older?
Do you have mantle cell lymphoma that has come back or hasn't responded well to prior treatments?
Are you willing to potentially receive one of the study treatments?
Are you able to attend regular hospital visits for check-ups and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to one of the treatment groups mentioned (either Ibrutinib plus Rituximab, or Lenalidomide/Bortezomib plus Rituximab). You'll receive your study medication as prescribed by the study doctors. This will involve taking pills and possibly having infusions (medication given through a drip).

You'll have regular hospital visits for check-ups, blood tests, and other assessments to monitor your health and how well the treatment is working. These visits might include scans or other procedures. The study will last for a certain period, and even after you stop taking the study medication, there will be follow-up appointments to see how you're doing in the long term. The exact number of visits and their frequency will be explained to you in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive new treatments that are not yet widely available, and you'll be closely monitored by a team of healthcare professionals. This could potentially lead to better control of your cancer. However, there are also potential risks, as all medications can have side effects. These can range from mild to more serious, and the study team will discuss all known potential side effects with you before you decide to participate. You have the right 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
Czechia
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Unverified
Spain
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Unverified
Poland

Common questions

What is mantle cell lymphoma?

It's a type of cancer that affects specific white blood cells in your body.

What does 'relapsed or refractory' mean?

It means the cancer has come back after treatment, or didn't respond well to previous treatments.

Will I know which treatment I'm getting?

Yes, in this study, you and your doctor will know which treatment you are receiving.

What's the main purpose of this study?

To find out which combination of treatments works best for mantle cell lymphoma that has come back or is difficult to treat.

Can I stop participating if I want to?

Yes, you can leave the study at any time without it affecting your future medical care.