Active not recruitingPHASE2INTERVENTIONAL

A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma

This study, called TrAVeRse, is for adults newly diagnosed with a type of blood cancer called Mantle Cell Lymphoma (MCL). It's testing a new treatment that combines three drugs – acalabrutinib, venetoclax, and rituximab. Unlike traditional treatments, this combination does not involve chemotherapy. The main goal is to see how well these three drugs work together to get rid of the cancer completely. After an initial treatment period, if a patient's cancer is completely gone, they will either continue with one of the drugs (acalabrutinib) or be closely watched without further treatment. This part helps doctors understand if some people can safely stop treatment. The study also looks at what happens if the cancer comes back.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

AstraZeneca

Enrolment target

108

Start

13 Dec 2023

Estimated completion

31 Oct 2028

Mantle Cell Lymphoma (MCL)

What is this study about?

Mantle Cell Lymphoma (MCL) is a type of cancer that affects specific white blood cells. When someone is diagnosed with MCL, they usually need treatment. While there are several ways to treat MCL, doctors are still looking for the best possible treatment that can cure the disease or keep it under control for a long time. Traditional treatments often involve chemotherapy, which can have significant side effects.

This study, called TrAVeRse, is trying a new approach. It's testing a combination of three different drugs: acalabrutinib, venetoclax, and rituximab. These drugs work in different ways to fight cancer without using chemotherapy. Acalabrutinib is a type of drug that blocks a protein important for cancer growth, venetoclax targets another protein that helps cancer cells survive, and rituximab is an antibody that helps your immune system find and destroy cancer cells. The aim is to see if this combination is effective for people who have just been diagnosed with MCL and haven't started treatment yet.

A key part of the study is to find out if, after an initial period of treatment, patients who respond very well (meaning their cancer is completely gone, even at a very tiny level) can safely stop all treatment or continue with just one drug (acalabrutinib). This could mean less ongoing treatment and fewer side effects for some patients in the future. The study will also look at what happens if the cancer returns, and if one of the drugs, acalabrutinib, can be used again to help.

Key takeaways

This study is for adults newly diagnosed with Mantle Cell Lymphoma.
It tests a new chemotherapy-free combination of three drugs.
The main goal is to see if this treatment can clear the cancer at a deep level.
After initial treatment, some patients might be able to reduce or stop their therapy.
Participation involves taking tablets and having infusions, plus regular check-ups.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be at least 18 years old and have been newly diagnosed with Mantle Cell Lymphoma. Your doctor must agree that you need treatment for your MCL. You'll also need to have clear signs of the disease that can be measured, either enlarged lymph nodes or spleen, or specific involvement in your bone marrow.

It's important that your general health is good enough to take part in the study. Doctors use a special scale to check this, and you would generally need to be able to carry out your normal daily activities without much trouble. The study will also need to review samples of your cancer cells to confirm specific changes that point to MCL and to help with the study's tests.

There are also other medical conditions or treatments that might mean you can't join the study, to make sure it's safe for you. Your blood test results, such as your kidney and liver function, will also need to be within certain limits. Your study doctor will go through all the detailed requirements with you to see if this study is a good fit.

Quick self-check

Are you 18 years old or older?
Have you recently been diagnosed with Mantle Cell Lymphoma and not yet started treatment?
Do you have measurable signs of the lymphoma, like enlarged lymph nodes, spleen, or bone marrow involvement?
Is your general health good enough for you to do most of your daily activities?
Are you willing to provide tissue samples for testing?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will receive a combination of three drugs: acalabrutinib, venetoclax, and rituximab. Acalabrutinib will be taken as tablets twice a day, venetoclax as tablets once a day (starting from the second month), and rituximab will be given into your vein once a month. This initial treatment period will last for 13 cycles, with each cycle lasting 28 days, so about 13 months in total.

During this time, you will have regular hospital visits for infusions, blood tests, physical exams, and scans to check how you are responding to the treatment. After these 13 cycles, if the tests show your cancer is completely gone, you will then be randomly assigned to either continue taking just acalabrutinib tablets or to be closely monitored without any further cancer treatment. This second phase could last for a longer time, depending on which group you are in and how you respond.

If you are in the group that stops treatment and your cancer returns, you might be offered acalabrutinib again. The total length of your participation in the study could vary, potentially lasting several years, as doctors will continue to monitor your health and how the treatment is working. Throughout the study, you'll have regular follow-up appointments and tests.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new, chemotherapy-free treatment for Mantle Cell Lymphoma that might be more effective or have different side effects compared to standard treatments. You would also be closely monitored by a dedicated medical team. However, like all medical treatments, there are potential risks. The study drugs may cause side effects, which can range from mild to serious and could include tiredness, infections, bleeding, or stomach issues. The study involves regular hospital visits, blood tests, and scans, which can be time-consuming and may cause some discomfort. It's important to remember that you are free to withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (29)

Research Site
Hackensack, United States
Research Site
Stony Brook, United States
Research Site
Cleveland, United States
Research Site
Philadelphia, United States
Research Site
Houston, United States
Research Site
Heidelberg, Australia
Research Site
Kogarah, Australia
Research Site
Nedlands, Australia
Research Site
Sydney, Australia
Research Site
Porto Alegre, Brazil
Research Site
Rio de Janeiro, Brazil
Research Site
São Paulo, Brazil

+17 more sites — see the official record for the full list.

Common questions

What is Mantle Cell Lymphoma (MCL)?

Mantle Cell Lymphoma is a rare type of cancer that starts in certain white blood cells (lymphocytes). It affects the lymph nodes, spleen, bone marrow, and sometimes other organs.

What does 'treatment-naïve' mean?

It means you have recently been diagnosed with Mantle Cell Lymphoma and have not yet received any treatment specifically for this condition.

Are these drugs chemotherapy?

No, the drugs used in this study (acalabrutinib, venetoclax, and rituximab) are not chemotherapy. They are targeted therapies and an antibody treatment that work in different ways to fight cancer cells.

What is 'MRD-negative complete response'?

This means that after treatment, tests show no signs of cancer cells, not even tiny amounts that are usually hard to find. It's a very good response to treatment.

Can I stop study treatment if I want to?

Yes, you can choose to leave the study at any time, for any reason, without affecting your regular medical care.