Active not recruitingPHASE2INTERVENTIONAL

Copanlisib and Rituximab in Marginal Zone Lymphoma Patients

This study is investigating a new treatment for Marginal Zone Lymphoma (MZL), a type of slow-growing blood cancer. Researchers are combining two medicines, Copanlisib and Rituximab, to see if they can effectively treat MZL without using traditional chemotherapy. Chemotherapy can have difficult side effects, particularly for older individuals who often have MZL. The goal is to find a treatment that works well, like the current options that include chemotherapy, but with fewer harsh side effects. This combination is being tested in patients newly diagnosed or whose MZL has come back, who need treatment and either can't have local treatments or those treatments haven't worked.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Christian Buske

Enrolment target

Start

15 Dec 2019

Estimated completion

31 Dec 2027

Marginal Zone Lymphoma

What is this study about?

This study is looking at a new way to treat a type of cancer called Marginal Zone Lymphoma (MZL). MZL is a slow-growing cancer that affects white blood cells. Currently, a common treatment for MZL involves a medicine called Rituximab along with chemotherapy. While this combination can work well for many, it often causes side effects that can be particularly difficult for older patients, who make up a large number of people with MZL. Also, even with successful treatment, the cancer can sometimes return later.

Because of these challenges, doctors are very interested in finding treatments for MZL that don't involve chemotherapy but are still effective. This study is testing a new combination of two chemotherapy-free medicines: Copanlisib and Rituximab. Rituximab is already used for MZL, and Copanlisib has shown promise in treating similar types of blood cancers. The main idea behind this study is to see if combining these two medicines can be as good, or even better, than current treatments that use chemotherapy, but with fewer of the tough side effects.

They want to find out if this new combination is effective and safe for patients who have been recently diagnosed with MZL or whose MZL has returned. It's specifically for those who need treatment but can't have or haven't responded to other local treatments, like surgery or radiation. The hope is that this chemotherapy-free approach could offer a new, gentler yet powerful option for people living with MZL.

Key takeaways

Tests a new chemotherapy-free option for MZL.
Combines Copanlisib and Rituximab.
Aims for fewer side effects than chemotherapy.
For newly diagnosed or relapsed MZL patients in need of treatment.
Specifically for those unsuitable for or who failed local treatments.
Studies safety and effectiveness of this new combination.

Who may be eligible?

To join this study, people generally need to be at least 18 years old and have been diagnosed with Marginal Zone Lymphoma (MZL) that tests positive for CD20. This could be a new diagnosis or the MZL has returned. Importantly, participants must need treatment for their MZL because it's causing symptoms, and they either can't have local treatments (like surgery or radiation) or those treatments haven't worked for them.

The specific type of MZL matters. It includes MALT Lymphoma that started in places other than the stomach, splenic MZL (which affects the spleen), and nodal MZL (which affects lymph nodes). For most types, doctors will need to have a sample of the cancer tissue to confirm the diagnosis within the last year. If it's splenic MZL and a spleen sample isn't available, other tests like blood and bone marrow analysis might be used. For some types, the cancer also needs to be a certain size to be measured properly.

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 or older?
Do you have a confirmed diagnosis of CD20 positive Marginal Zone Lymphoma (MZL)?
Does your MZL require treatment (e.g., causing symptoms)?
Have you not been able to have local treatments (like surgery/radiation) or have they not worked for you?
Is your MZL of a type suitable for the study (MALT, splenic, or nodal MZL)?

Answer every question to see your result.

What does participation involve?

This is a Phase 2 study, which means researchers are checking how safe and effective the new combination of Copanlisib and Rituximab is. You would receive both medicines. The study would involve regular visits to the hospital for treatments, blood tests, and check-ups to monitor your health and how you're responding to the treatment. This includes looking for any side effects. The exact number of visits, assessments, and the full length of the study would be explained in detail by the study team, along with how often you'd get the medication and how long the follow-up period would be to make sure everything is stable.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new, potentially effective, and less toxic treatment for your MZL, especially if standard chemotherapy options are not suitable for you. However, as with all medical treatments, there are potential risks and side effects from Copanlisib and Rituximab that are not yet fully known in this combination. These will be thoroughly explained by the study doctor. You will have a clear understanding of any potential side effects and what can be done to manage them. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (18)

Med. Uni Wien AKH, Klinische Abteilung für Onkologie, Innere Medizin I
Verified postcode
Vienna, Austria
St. Josef-Hospital, Medizinische Klinik I
Verified postcode
Bochum, Germany
Johanniter GmbH, Johanniter-Krankenhaus
Verified postcode
Bonn, Germany
ÜBAG MVZ Dr. Vehling-Kaiser GmbH Dingolfing
Verified postcode
Dingolfing, Germany
Kath. Karl-Leisner-Klinikum gGmbH, Betriebsstätte Wilhelm-Anton-Hospital
Verified postcode
Goch, Germany
MVZ Goslar, MVZ Onkologische Kooperation Harz
Verified postcode
Goslar, Germany
Universitätsklinikum Halle, Klinik und Poliklinik für Innere Medizin
Verified postcode
Halle, Germany
Rotes Kreuz Krankenhaus, Klinik für Interdisziplinäre Onkologie
Verified postcode
Kassel, Germany
ÜBAG MVZ Dr. Vehling-Kaiser GmbH
Verified postcode
Landshut, Germany
Gemeinschaftspraxis, Fachärzte für Innere Medizin
Verified postcode
Mannheim, Germany
Universitätsmedizin Mannheim, III. Medizinische Klinik
Verified postcode
Mannheim, Germany
Kliniken Ostalb Stauferklinikum Schwäbisch Gmünd, Zentrum für Innere Medizin
Verified postcode
Mutlangen, Germany

Common questions

What is Marginal Zone Lymphoma (MZL)?

MZL is a type of slow-growing cancer that affects white blood cells called lymphocytes.

What are Copanlisib and Rituximab?

These are two different medicines for cancer. Rituximab is an antibody, and Copanlisib is a targeted medicine. They are being tested together without chemotherapy.

What does 'chemotherapy-free' mean?

It means the treatment does not use traditional chemotherapy drugs, which generally have more severe side effects.

Who is this study for?

It's for people with newly diagnosed or relapsed MZL who need treatment and can't have or respond to local therapies.

What is a Phase 2 study?

A Phase 2 study checks if a new treatment is effective and safe in a larger group of patients after initial safety tests.