RecruitingPHASE2INTERVENTIONAL

Efficacy of Venetoclax in Combination With Rituximab in Waldenström's Macroglobulinemia

This research is looking for a better way to treat Waldenström's macroglobulinemia (WM), a type of blood cancer, especially for people who are newly diagnosed. Many current treatments use chemotherapy, which can be tough on patients, particularly older ones. This study aims to find out if a combination of two drugs, Venetoclax and Rituximab, used for a set period, can be more effective and gentler than chemotherapy. We want to see if this new approach can lead to better outcomes, like stronger responses and fewer side effects, potentially changing how WM is treated in the future. The goal is to provide a more manageable and effective option for patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Christian Buske

Enrolment target

Start

21 Mar 2025

Estimated completion

01 Mar 2033

Waldenstrom Macroglobulinemia Treatment Naive

What is this study about?

Waldenström's macroglobulinemia (WM) is a type of blood cancer that often affects older people. Current treatments, which often involve chemotherapy, can sometimes be difficult to tolerate and may not offer long-lasting relief for everyone. Doctors are always looking for new and gentler ways to treat WM that are also highly effective.

This study is exploring a new treatment idea that doesn't involve chemotherapy. It combines two medicines called Venetoclax and Rituximab. Venetoclax has already been approved for other similar blood cancers because it works well and generally has fewer side effects. Rituximab is a common drug used in treating many blood cancers. The hope is that by combining these two medicines for a specific period, we can achieve better results than traditional chemotherapy, without the harsh side effects often linked to chemotherapy.

Researchers believe that this combination could lead to deeper and longer-lasting responses for people newly diagnosed with WM, regardless of specific genetic markers in their cancer. If this study shows promising results, it could pave the way for a larger study and potentially change the standard way WM is treated, offering patients a more effective and manageable treatment journey.

Key takeaways

This study is for people newly diagnosed with Waldenström's macroglobulinemia (WM).
It aims to find a chemotherapy-free treatment option.
It compares two drugs, Venetoclax and Rituximab, against standard chemotherapy-based treatment.
The new treatment is given for a fixed period (around 12 months).
The goal is to find a treatment that is both effective and has fewer side effects.

Who may be eligible?

To join this study, doctors must have confirmed that you have Waldenström's macroglobulinemia (WM) that has not been treated before. You'll also need to be experiencing symptoms that show treatment is necessary, such as feeling very tired, having night sweats, losing weight, experiencing particular blood issues like low haemoglobin or platelets, or having enlarged organs or symptoms from your WM affecting your nerves or other body parts.

You must be at least 18 years old and generally healthy enough to participate, with a good heart function and an estimated life expectancy of more than three months. Your overall physical ability to carry out daily activities will also be checked to make sure you can safely take part in the study.

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.

Have you been diagnosed with Waldenström's macroglobulinemia (WM)?
Have you not received any prior treatment for your WM?
Are you 18 years old or older?
Are you currently experiencing symptoms from your WM, such as fatigue or major issues with your blood counts or organs?
Do you feel generally well enough to participate in a study, or have a good 'performance status'?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either the new combination of Venetoclax and Rituximab or a standard treatment that includes Rituximab and chemotherapy. The Venetoclax and Rituximab will be given for a specific period of about 12 months. Your health will be closely monitored with regular check-ups, blood tests, and other assessments to see how you are responding to the treatment and to check for any side effects. The total duration of your participation will involve the treatment period and follow-up appointments to track your long-term health and the effectiveness of the treatment.

Potential risks and benefits

Taking part in a clinical trial might offer the benefit of receiving a new treatment that could be more effective or have fewer side effects than current options. However, there's always a chance that the new treatment might not work as well, or it could have unexpected side effects. All possible side effects will be carefully monitored, and you will be fully informed before you decide to participate. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (14)

Onkologische Schwerpunktpraxis Bielefeld
Verified postcode
Bielefeld, Germany· Recruiting
Klinikum Chemnitz gGmbH
Verified postcode
Chemnitz, Germany· Recruiting
Klinikverbund Allgaeu gGmbH
Verified postcode
Kempten, Germany· Recruiting
Universitaetsklinikum Schleswig-Holstein AöR
Verified postcode
Kiel, Germany· Recruiting
Gemeinschaftsklinikum Mittelrhein gGmbH
Verified postcode
Koblenz, Germany· Recruiting
Dr. Vehling-Kaiser MVZ GmbH
Verified postcode
Landshut, Germany· Recruiting
Kliniken Maria Hilf GmbH Moenchengladbach
Verified postcode
Mönchengladbach, Germany· Recruiting
Kliniken Ostalb, Standort Stauferklinikum Schwäbisch Gmünd
Verified postcode
Mutlangen, Germany· Not yet recruiting
Haematologie und Onkologie Muenchen-Pasing MVZ GmbH
Verified postcode
München, Germany· Recruiting
Universitaet Muenster
Verified postcode
Münster, Germany· Recruiting
Christliches Klinikum Paderborn, Brüderkrankenhaus St. Josef Paderborn
Verified postcode
Paderborn, Germany· Recruiting
Universitätsmedizin Rostock
Verified postcode
Rostock, Germany· Not yet recruiting

Common questions

What is Waldenström's macroglobulinemia (WM)?

It's a rare type of slow-growing blood cancer that affects white blood cells called B-cells.

What does 'treatment naive' mean?

It means you have recently been diagnosed with WM and haven't had any treatment for it yet.

What are Venetoclax and Rituximab?

They are different types of medicines used to treat certain blood cancers. Venetoclax stops cancer cells from surviving, and Rituximab helps your immune system target cancer cells.

Is this a new treatment for WM?

The combination of Venetoclax and Rituximab for newly diagnosed WM is being tested in this study to see if it's better than current treatments.

Will I get chemotherapy in this study?

One group in the study will receive the chemotherapy-free combination, while another group will receive a standard treatment that includes chemotherapy and Rituximab. You won't choose which treatment you get.

How to find out more

Dajana Kaszynski, MSc

studien.gla@uniklinik-ulm.de +49 731 500 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.