AuthorisedTherapeutic confirmatory (Phase III)Interventional

HOVON 182 CLL: Prospective randomized phase 3 study of treatment with rituximab (6 cycles) in combination with 6 or 26 cycles of venetoclax in patients with relapsed or refractory chronic lymphocytic leukemia RED RIVER CLL study: Reduced Duration Rituximab VEnetoclax in Relapsed/refractory CLL

This research study, called HOVON 182 CLL (also known as RED RIVER CLL), is for people in the UK with a type of blood cancer called chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) that has either returned or not responded to past treatments. The study is comparing two different durations of treatment with a medicine called venetoclax (brand name Venclyxto), given along with another medicine called rituximab. Participants will receive rituximab for 6 cycles, but will either take venetoclax for 6 cycles or for a longer period of 26 cycles. The main goal is to see if the shorter venetoclax treatment is just as effective at keeping the cancer under control and preventing it from getting worse, while potentially reducing side effects and impact on daily life.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

Enrolment target

456

Start

08 Jun 2026

Relapsed or refractory small lymphocytic lymphoma, Relapsed or refractory chronic lymphocytic leukemia

What is this study about?

This study is called HOVON 182 CLL, also known as RED RIVER CLL. It's designed for people who have chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) that has come back after treatment or hasn't responded well to previous treatments. CLL is a type of cancer that affects white blood cells, and SLL is a very similar condition. The aim of this research is to find the best way to treat these conditions.

The study focuses on a treatment plan that uses two medicines together: rituximab and venetoclax (which you might know as Venclyxto). Rituximab is given for 6 cycles to everyone in the study. However, the study is comparing two different lengths of time for taking venetoclax: either a shorter course of 6 cycles or a longer course of 26 cycles. The main reason for this is to see if a shorter treatment time with venetoclax can be just as good at keeping the cancer under control. If it is, this could mean fewer side effects and a better quality of life for patients.

Researchers will be carefully watching how well these different treatment approaches work. They will look at things like how long patients stay free from their cancer getting worse, how long they live, and their overall health and quality of life. The information gathered from this study will help doctors understand if a shorter, but possibly more convenient and less demanding, treatment plan with venetoclax is a good option for people with relapsed or refractory CLL/SLL.

Key takeaways

This study compares different lengths of venetoclax treatment for CLL or SLL that has come back or not responded to previous therapy.
It aims to see if a shorter treatment course is just as effective as a longer one.
You would receive rituximab plus either 6 or 26 cycles of venetoclax.
The study assesses how well the cancer is controlled, quality of life, and side effects.
Participation involves regular hospital visits for treatment and check-ups.
It's a Phase 3 study, meaning it's in the final stages of testing before a new treatment might become widely available.

Who may be eligible?

The study is for people aged 18 or older. Both men and women can take part.

To be considered for this study, you must have chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) that has either returned after previous treatment or has not responded well enough to past treatments.

Your doctor will check other specific medical details, including your general health and other test results, to make sure this study is the right and safest option for you. Not everyone with CLL or SLL will be suitable, as there are strict guidelines to protect your safety and ensure the results of the study are reliable.

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 chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)?
Has your CLL/SLL come back after treatment, or not responded well to previous treatments?
Are you able to take venetoclax tablets and receive rituximab by IV drip?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned by chance (like flipping a coin) to one of two treatment groups. Both groups will receive the drug rituximab for 6 cycles. The difference will be how long you take venetoclax (Venclyxto); one group will take it for 6 cycles, and the other group will take it for 26 cycles. Your treatment will involve taking venetoclax tablets and receiving rituximab through an IV drip.

You will have regular hospital visits for check-ups, blood tests, and to receive your rituximab treatment. These visits will allow the medical team to see how you are responding to the treatment and to monitor for any side effects. You will also be asked to complete questionnaires about your health and how you are feeling (quality of life). The study will follow you over a period of time to track your progress, even after your main treatment cycles are complete. The total duration of your participation, including follow-up, will depend on your assigned treatment group and how your condition progresses, but it will involve ongoing assessments.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to new treatments like the venetoclax combinations being studied, which could help manage your condition. You will also receive careful monitoring from a dedicated medical team. However, there are also potential risks. The medicines used can cause side effects, and some may be serious. The study team will explain these expected side effects to you in detail. There is also no guarantee that the treatment will be effective for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your future 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
Netherlands

Common questions

What is chronic lymphocytic leukaemia (CLL)?

CLL is a type of cancer that affects certain white blood cells and usually develops slowly. Small lymphocytic lymphoma (SLL) is a very similar condition.

What does 'relapsed or refractory' mean?

It means the cancer has either returned after you've had treatment for it before, or it hasn't responded well to previous treatments.

What are venetoclax (Venclyxto) and rituximab?

These are medicines used to treat certain blood cancers. Venetoclax is usually taken as a tablet, and rituximab is given through a drip.

Why are they studying different lengths of venetoclax treatment?

Researchers want to find out if a shorter course of venetoclax works as well as a longer course. If it does, it could mean fewer visits and side effects for patients.

Will I know which treatment group I'm in?

No, you will be assigned to a group by chance. This helps to make sure the study results are fair and unbiased.