AuthorisedTherapeutic confirmatory (Phase III)Interventional

A prospective, open-label, randomized, multicenter phase-III trial to evaluate the efficacy of pirtobrutinib and epcoritamab compared with R-(mini)-CHOP for treatment of patients with Richter Transformation - CLLRT2

This research study, called CLLRT2, is looking for people with a specific type of lymphoma called Richter Transformation who haven't had treatment for it before. It's a 'Phase III' trial, which means it's comparing new treatments, pirtobrutinib and epcoritamab, with a standard treatment named R-(mini)-CHOP. The main goal is to find out if the new drug combinations can keep the cancer from growing for a longer time than the standard treatment. The study will also look at how many people respond to the treatments, how long those responses last, and overall survival. Both men and women aged 18 and over can potentially take part.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

University Of Cologne

Enrolment target

Start

18 Mar 2026

previously untreated RT irrespective of risk factors and disease stage

What is this study about?

This study is for people who have been diagnosed with something called Richter Transformation and haven't had treatment for it yet. Richter Transformation is a type of lymphoma that can develop in people with a condition called Chronic Lymphocytic Leukaemia (CLL). It's a serious condition, and doctors are always looking for better ways to treat it.

In this study, researchers want to see if newer treatment combinations are more effective than the current standard treatment. The standard treatment in this study is called R-(mini)-CHOP, which is a type of chemotherapy. The new treatments involve drugs called pirtobrutinib and epcoritamab, which work in different ways to fight cancer cells. By comparing these treatments, doctors hope to find out if the new drugs can stop the cancer from getting worse for a longer period.

The main thing the doctors will be measuring is how long people go without their cancer growing or getting worse. This is called 'progression-free survival'. They will also look at other important things like how many people's cancer shrinks or disappears completely, how long they live, and how long they can go without needing another treatment. This research is important because it could lead to better treatment options for people with Richter Transformation in the future.

Key takeaways

This study is for adults with previously untreated Richter Transformation.
It compares new drug combinations with a standard chemotherapy treatment.
The main goal is to see if new treatments can stop cancer growth for longer.
You will receive either the new drugs or standard chemotherapy.
Regular hospital visits and tests will be part of your participation.
You can stop participating at any time.

Who may be eligible?

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

The most important requirement is that you have been diagnosed with Richter Transformation and have not received any treatment for this condition before. It doesn't matter what your specific risk factors or the stage of your disease are.

There will be other medical checks and criteria that the study doctors will need to go through with you to make sure it's safe and appropriate for you to participate.

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 Richter Transformation?
Have you NOT had any treatment for your Richter Transformation yet?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of the treatment groups. You will either receive the standard R-(mini)-CHOP chemotherapy or one of the new drug combinations involving pirtobrutinib and epcoritamab, sometimes with other medications like Prednisolone or Cyclophosphamide. The specific drugs you receive will be given as tablets, injections, or infusions (drips).

You will have regular hospital visits, where doctors will monitor your health, give you your medication, and carry out various tests. These tests might include blood tests, scans, and physical examinations to see how you are responding to the treatment and to check for any side effects. The exact number and frequency of visits, as well as the total duration of your participation, will be explained in detail by the study team. You will also have follow-up appointments after your main treatment period to monitor your long-term health and any effects of the treatment.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new treatments before they are widely available, and close monitoring by medical experts. However, there are also potential risks; new treatments may have side effects that are not yet fully known, and there's no guarantee that the treatment will be more effective than standard care. You might experience side effects from the drugs, and some treatments might not work for you. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

—
Unverified
Austria
—
Unverified
Germany
—
Unverified
Denmark
—
Unverified
Ireland

Common questions

What is Richter Transformation?

It's a type of lymphoma that can develop in some people who have Chronic Lymphocytic Leukaemia (CLL).

What is a 'Phase III' trial?

It means the study is comparing a new treatment with a standard treatment to see if the new one is better or safer.

What does 'progression-free survival' mean?

It's how long a person lives without their cancer growing or getting worse.

Will I know which treatment I'm getting?

This is an 'open-label' study, which means both you and your doctor will know which treatment you are receiving.

What if I change my mind after joining?

You can withdraw from the study at any time without having to give a reason, and it won't affect your future medical care.